Calibrator, Secondary

FDA product code JIT · 231 cleared devices

Class 2 Clinical Chemistry

Regulation: 21 CFR 862.1150
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1976-10-05 – 2017-05-16

JIT 1982-09-21

SERA CHEM SMAC CALIBRATORS

Applicant Fisher Scientific Co., LLC

K number K822496

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JIT 1982-09-14

BILIRUBIN CALIBRATOR #65071

Applicant Emd Chemicals, Inc.

K number K822479

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JIT 1982-09-14

ALBUMIN STANDARD, #65070

Applicant Emd Chemicals, Inc.

K number K822478

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JIT 1982-09-14

TOTAL PROTEIN STANDARD, #65074

Applicant Emd Chemicals, Inc.

K number K822475

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JIT 1982-09-02

BILIRUBIN CALIBRATORS

Applicant Gilford Diagnostics

K number K822334

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JIT 1980-12-11

CHOLESTEROL STANDARDS

Applicant Mallinckrodt Critical Care

K number K802823

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JIT 1980-04-21

SLAVO CHOLESTEROL STAND. DIAGNOSTIC KIT

Applicant Sclavo, Inc.

K number K800770

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JIT 1980-02-26

CALIBRATOR NO. 1 & 2, & WASH SOLUTION

Applicant Fisher Scientific Co., LLC

K number K800220

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JIT 1979-12-06

TSH STANDARDS & DILUENT

Applicant Amersham Corp.

K number K792290

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JIT 1979-08-16

CATALOG #4-2520 CHLORIDOMETER CHLORIDE

Applicant Buchler Instruments, Inc.

K number K791312

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JIT 1978-08-31

DUAL COMPONENT STANDARDS

Applicant Abbott Laboratories

K number K781423

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JIT 1978-08-14

STANDARDS, HORMONE, THYROID STIMULATING

Applicant Pcl-Ria, Inc.

K number K781071

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JIT 1978-08-14

T3 STANDARDS IN HUMAN SERUM

Applicant Pcl-Ria, Inc.

K number K781069

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JIT 1978-08-10

TRAP-BLOOD VESSEL STABILIZATION DEVICE

Applicant Ayer, Patrick, M.D.

K number K781072

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JIT 1978-06-22

URIC ACID REFERENCE SERA

Applicant Macomb Chemical Co.

K number K780447

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JIT 1978-04-05

CALIBRATORS, CARBON DIOXIDE

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K780295

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JIT 1978-02-28

FLAME PHOTOMETER STANDARD

Applicant Alko Scientific Co.

K number K772153

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JIT 1977-12-06

PH CALIBRATION BUFFERS

Applicant General Diagnostics

K number K772106

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JIT 1977-10-25

ACA AMMONIA CALIBRATOR

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K771804

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JIT 1977-10-25

ACA PHOSPHORUS CALIBRATOR

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K771803

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JIT 1977-10-25

ACA IRON CALIBRATOR

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K771802

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JIT 1977-10-25

ACA CARBON DIOXIDE CALIBRATOR

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K771801

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JIT 1977-10-25

ACA TRIGLYCERIDE CALIBRATOR

Applicant E.I. Dupont DE Nemours & Co., Inc.

K number K771797

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JIT 1977-07-21

CENTRIFICHEM TRIGLYCEOIDE CALI, STD. SET

Applicant Union Carbide Corp.

K number K771216

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JIT 1977-07-21

CENTRIFICHEM TRIGLYCERIDE CALI. STD.

Applicant Union Carbide Corp.

K number K771215

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JIT 1977-07-11

INORGANIC PHOSPHORUS STANDARDS

Applicant Worthington Biochemical Corp.

K number K771143

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JIT 1977-03-01

CHOLESTEROL STANDARDS

Applicant Worthington Biochemical Corp.

K number K770277

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JIT 1977-01-31

CENTRIFICHEM 200MG/DL CHOL. CAL. STD.

Applicant Union Carbide Corp.

K number K770127

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JIT 1977-01-31

CENTRIFICHEM CHOLES. CALIB. STD. SET

Applicant Union Carbide Corp.

K number K770126

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JIT 1976-12-21

CHOLESTEROL CALIBRATOR

Applicant Beckman Instruments, Inc.

K number K761197

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JIT 1976-10-05

BILIRUBIN REF., SIGMA STOCK NO. 605-10

Applicant Sigma Chemical Co.

K number K760349

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