FDA Product Code
FDA Product Code CEP — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1485
510(k) Clearances — 143 records · page 2 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K860308 | SUCROSEP LUTEINIZING HORMONE (LH) IRMA | Boots-Celltech Diagnostics, Inc. | 1986-03-17 | Traditional | PDF ↗ |
| K855173 | DELFIA TM HLH KIT | Lkb Instruments, Inc. | 1986-02-28 | Traditional | PDF ↗ |
| K854838 | LEE-BEAD BETA LH (EIA) | Leeco Diagnostics, Inc. | 1986-01-07 | Traditional | PDF ↗ |
| K853142 | OVUTIME OVULATION PREDICTOR TEST | Advanced Care Products | 1985-12-17 | Traditional | PDF ↗ |
| K853837 | LH/FSH RADIOIMMUNOASSAY KIT | Bioclinical Group | 1985-10-16 | Traditional | PDF ↗ |
| K852146 | QUIDEL QUEST OVULATION TEST | Quidel Corp. | 1985-07-29 | Traditional | PDF ↗ |
| K851445 | COLOR OVULATION TEST | Nms Pharmaceuticals, Inc. | 1985-07-29 | Traditional | PDF ↗ |
| K851332 | BLHI LUTEINIZING HORMONE | Euro-Diagnostics BV | 1985-07-09 | Traditional | PDF ↗ |
| K852376 | SIMULTANEOUS LH/FSH SYSTEM BY RIA | American Bioclinical, Inc. | 1985-07-09 | Traditional | PDF ↗ |
| K851104 | AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT | Amersham Corp. | 1985-04-10 | Traditional | PDF ↗ |
| K850480 | OVU STICK SELF-TEST -MODIFICATION | Monoclonal Antibodies, Inc. | 1985-03-05 | Traditional | PDF ↗ |
| K843284 | OVUSTICK SELF-TEST | Monoclonal Antibodies, Inc. | 1984-12-11 | Traditional | PDF ↗ |
| K841545 | ENZYME IMMUNOASSAY FOR DETECTION HORM | Btc Diagnostics, Inc. | 1984-11-27 | Traditional | PDF ↗ |
| K842445 | LH RIA | Syncor Intl. Corp. | 1984-09-04 | Traditional | PDF ↗ |
| K840412 | OVU STICK URINE HLH KIT | Monoclonal Antibodies, Inc. | 1984-04-13 | Traditional | PDF ↗ |
| K840188 | MICROMEDIC LH & FSH RIA KIT | Micromedic Systems | 1984-03-23 | Traditional | PDF ↗ |
| K840174 | LH QUIK RIA KIT | Pacific Biotech, Inc. | 1984-03-19 | Traditional | PDF ↗ |
| K833854 | LH RIA | Syncor Intl. Corp. | 1984-01-13 | Traditional | PDF ↗ |
| K833376 | RIANEN LUTEINIZING HORMONE RIA KIT | New England Nuclear | 1983-12-20 | Traditional | PDF ↗ |
| K823476 | GAMMADAB LH RADIO-KIT #CA-1508 | Clinical Assays, Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K823380 | 125-I LH RADIOIMMUNOASSAY KIT | Clinetics Corp. | 1982-12-22 | Traditional | PDF ↗ |
| K822288 | LH (125I) RADIOIMMUNOASSAY | Corning Medical & Scientific | 1982-09-13 | Traditional | PDF ↗ |
| K821346 | QUANTIMUNE HLH RIA | Bio-Rad | 1982-05-28 | Traditional | PDF ↗ |
| K820760 | LH RADIOIMMUNOASSAY TEST SYSTEM | Monobind | 1982-04-16 | Traditional | PDF ↗ |
| K820741 | MR1 LUTROPIN RIA KIT | Microanalytic Research, Inc. | 1982-04-14 | Traditional | PDF ↗ |
| K820753 | AMERLEX LH RIA KIT (CODE IM2081) | Amersham Corp. | 1982-04-09 | Traditional | PDF ↗ |
| K820357 | LUTEINIZING HORMONE KIT | Pcl-Ria, Inc. | 1982-03-25 | Traditional | PDF ↗ |
| K813213 | SHARIA-LH RIA KIT FOR QUANTITATION HORMO | Intl. Immunoassay Laboratories, Inc. | 1981-12-22 | Traditional | PDF ↗ |
| K811994 | RADIOIMMUNOASSAY LUTEINIZING HORMONE | Endocrine-Metabolic Center | 1981-07-27 | Traditional | PDF ↗ |
| K811024 | LUTEINIZING HORMONE DIRECT RIA KIT 125/I | Immunalysis Corporation | 1981-05-08 | Traditional | PDF ↗ |
| K810662 | LEECO LH-QUANT DIAGNOSTIC KIT | Leeco Diagnostics, Inc. | 1981-03-31 | Traditional | PDF ↗ |
| K810754 | LUTENIZING HORMONES | Pcl-Ria, Inc. | 1981-03-31 | Traditional | PDF ↗ |
| K810741 | LUTEINIZING HORMONE | Pcl-Ria, Inc. | 1981-03-31 | Traditional | PDF ↗ |
| K810302 | QUANTIMUNE HLH RIA HUMAN LUTENIZING HORM | Bio-Rad | 1981-02-25 | Traditional | PDF ↗ |
| K803278 | LUTEINIZING HORMONE RADIOIMMUNOASSAY KIT | Immuno Nuclear Corp. | 1981-01-21 | Traditional | PDF ↗ |
| K800106 | LUTEINIZING HORMONE RADIOIMMUNOASSAY SYS | Radioimmunoassay, Inc. | 1980-02-13 | Traditional | PDF ↗ |
| K792350 | CENTRIA LH RIA | Union Carbide Corp. | 1980-01-16 | Traditional | PDF ↗ |
| K792000 | LUTEINIZING HORMONE (LH) RIA | Cis Radiopharmaceuticals, Inc. | 1979-10-30 | Traditional | PDF ↗ |
| K791405 | 125I LEUTINIZING HORMONE RIA KIT | Diagnostic Products Corp. | 1979-09-17 | Traditional | PDF ↗ |
| K781685 | RIA KIT, LH | Amersham Corp. | 1978-10-27 | Traditional | PDF ↗ |
| K780576 | 125-I LABELED HUMAN LUTEINIZING HORMONE | Pcl-Ria, Inc. | 1978-05-19 | Traditional | PDF ↗ |
| K780367 | RIA SYS. FOR HUMAN LUTEINIZING HORMONE | Calbiochem-Behring Corp. | 1978-04-28 | Traditional | PDF ↗ |
| K770854 | LUTEINIZING HORMONE RIA REAGENT, LH-RIA | Nichols Institute Diagnostics | 1977-05-26 | Traditional | PDF ↗ |
Product code CEP · Class I · Clinical Chemistry. Data: openFDA.