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FDA 510(k)

BOVINE CHEMISTRY CONTROL I.X. & II.X.

K-Number: K812583 · 1981-09-24

ApplicantAmerican Dade
Decision Date1981-09-24
Product CodeJJY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

BOVINE CHEMISTRY CONTROL I.X. & II.X. is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1981-09-24 under 510(k) number K812583. The device is classified under product code JJY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BOVINE CHEMISTRY CONTROL I.X. & II.X.?

BOVINE CHEMISTRY CONTROL I.X. & II.X. is a medical device that received FDA 510(k) clearance on 1981-09-24. The listed applicant is American Dade. The 510(k) number is K812583.

When did BOVINE CHEMISTRY CONTROL I.X. & II.X. receive FDA 510(k) clearance?

BOVINE CHEMISTRY CONTROL I.X. & II.X. received FDA 510(k) clearance on 1981-09-24, under 510(k) number K812583.

Who is the listed applicant for BOVINE CHEMISTRY CONTROL I.X. & II.X.?

The FDA 510(k) record lists American Dade as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for BOVINE CHEMISTRY CONTROL I.X. & II.X.?

The FDA product code for BOVINE CHEMISTRY CONTROL I.X. & II.X. is JJY.

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Other records listing American Dade as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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Related Devices (Code: JJY)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K162530Multichem IA PlusTechno-Path ManufacturingK163629Audit MicroControls Linearity FD Tumor Markers IIAalto Scientific, Ltd.K163015Liquichek Tumor Marker Control-Level 1; Liquichek Tumor Marker Control-Level 2; Liquichek Tumor Marker Control-Level 3; Liquichek Tumor Marker Control- Trilevel MiniPakBio-Rad LaboratoriesK153712VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification KitRadiometer America, Inc.K132227LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-TRILEVEL, LIQUICHEK IMMUNOASSAY PREMIUM CONTROL-LEVEL I, LIQUICHEK IMMUNOASSAYBio-Rad LaboratoriesK132156RANDOX CSF CONTROLS LEVELS 2 AND 3Randox Laboratories, Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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