Radioimmunoassay, Luteinizing Hormone

FDA product code CEP · 143 cleared devices

Class 1 Clinical Chemistry

Regulation: 21 CFR 862.1485
Review panel: CH
Implant: No
Life sustaining: No
Third party review: No
GMP exempt: No
Clearance span: 1977-05-26 – 2003-01-16

CEP 1986-03-17

SUCROSEP LUTEINIZING HORMONE (LH) IRMA

Applicant Boots-Celltech Diagnostics, Inc.

K number K860308

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CEP 1986-02-28

DELFIA TM HLH KIT

Applicant Lkb Instruments, Inc.

K number K855173

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CEP 1986-01-07

LEE-BEAD BETA LH (EIA)

Applicant Leeco Diagnostics, Inc.

K number K854838

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CEP 1985-12-17

OVUTIME OVULATION PREDICTOR TEST

Applicant Advanced Care Products

K number K853142

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CEP 1985-10-16

LH/FSH RADIOIMMUNOASSAY KIT

Applicant Bioclinical Group

K number K853837

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CEP 1985-07-29

QUIDEL QUEST OVULATION TEST

Applicant Quidel Corp.

K number K852146

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CEP 1985-07-29

COLOR OVULATION TEST

Applicant Nms Pharmaceuticals, Inc.

K number K851445

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CEP 1985-07-09

SIMULTANEOUS LH/FSH SYSTEM BY RIA

Applicant American Bioclinical, Inc.

K number K852376

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CEP 1985-07-09

BLHI LUTEINIZING HORMONE

Applicant Euro-Diagnostics BV

K number K851332

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CEP 1985-04-10

AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT

Applicant Amersham Corp.

K number K851104

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CEP 1985-03-05

OVU STICK SELF-TEST -MODIFICATION

Applicant Monoclonal Antibodies, Inc.

K number K850480

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CEP 1984-12-11

OVUSTICK SELF-TEST

Applicant Monoclonal Antibodies, Inc.

K number K843284

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CEP 1984-11-27

ENZYME IMMUNOASSAY FOR DETECTION HORM

Applicant Btc Diagnostics, Inc.

K number K841545

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CEP 1984-09-04

LH RIA

Applicant Syncor Intl. Corp.

K number K842445

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CEP 1984-04-13

OVU STICK URINE HLH KIT

Applicant Monoclonal Antibodies, Inc.

K number K840412

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CEP 1984-03-23

MICROMEDIC LH & FSH RIA KIT

Applicant Micromedic Systems

K number K840188

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CEP 1984-03-19

LH QUIK RIA KIT

Applicant Pacific Biotech, Inc.

K number K840174

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CEP 1984-01-13

LH RIA

Applicant Syncor Intl. Corp.

K number K833854

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CEP 1983-12-20

RIANEN LUTEINIZING HORMONE RIA KIT

Applicant New England Nuclear

K number K833376

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CEP 1982-12-28

GAMMADAB LH RADIO-KIT #CA-1508

Applicant Clinical Assays, Inc.

K number K823476

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CEP 1982-12-22

125-I LH RADIOIMMUNOASSAY KIT

Applicant Clinetics Corp.

K number K823380

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CEP 1982-09-13

LH (125I) RADIOIMMUNOASSAY

Applicant Corning Medical & Scientific

K number K822288

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CEP 1982-05-28

QUANTIMUNE HLH RIA

Applicant Bio-Rad

K number K821346

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CEP 1982-04-16

LH RADIOIMMUNOASSAY TEST SYSTEM

Applicant Monobind

K number K820760

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CEP 1982-04-14

MR1 LUTROPIN RIA KIT

Applicant Microanalytic Research, Inc.

K number K820741

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CEP 1982-04-09

AMERLEX LH RIA KIT (CODE IM2081)

Applicant Amersham Corp.

K number K820753

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CEP 1982-03-25

LUTEINIZING HORMONE KIT

Applicant Pcl-Ria, Inc.

K number K820357

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CEP 1981-12-22

SHARIA-LH RIA KIT FOR QUANTITATION HORMO

Applicant Intl. Immunoassay Laboratories, Inc.

K number K813213

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CEP 1981-07-27