FDA Product Code
FDA Product Code CFL — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1370
510(k) Clearances — 36 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K972761 | SEALITE SCIENCES, INC. AQUALITE HUMAN GROWTH HORMONE ASSAY | Sealite Sciences, Inc. | 1997-09-25 | Traditional | PDF ↗ |
| K971353 | DSL ACTIVE NON-EXTRACTION IGF-I ELISA | Diagnostic Systems Laboratories, Inc. | 1997-05-12 | Traditional | PDF ↗ |
| K970701 | DSL 1900 ACTIVE HUMAN GROWTH HORMONE IRMA (DSL 1900) | Diagnostic Systems Laboratories, Inc. | 1997-04-02 | Traditional | PDF ↗ |
| K962758 | DSL 9100 IGF-II IRMA | Diagnostic Systems Laboratories, Inc. | 1996-08-30 | Traditional | PDF ↗ |
| K961678 | HUMAN GROWTH HORMONE IMMUNOASSAY KIT | Nichols Institute Diagnostics | 1996-07-08 | Traditional | PDF ↗ |
| K961172 | DSL ACTIVE NON-EXTRACTION IGF-I IRMA | Diagnostic Systems Laboratories, Inc. | 1996-04-23 | Traditional | PDF ↗ |
| K960551 | DSL ACTIVE HUMAN GROWTH HORMONE ELISA | Diagnostic Systems Laboratories, Inc. | 1996-03-06 | Traditional | PDF ↗ |
| K955376 | IMMULITE HGH | Diagnostic Products Corp. | 1996-02-16 | Traditional | PDF ↗ |
| K955390 | INSULIN-LIKE GROWTH FACTOR-I (IGF-I) IMMUNORADIOMETRIC ASSAY | Corning Nichols Diagnostics | 1995-12-29 | Traditional | PDF ↗ |
| K952505 | INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) | Nichols Institute | 1995-07-03 | Traditional | PDF ↗ |
| K946247 | IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 | Nichols Institute | 1995-06-23 | Traditional | PDF ↗ |
| K951752 | ACTIVE IGF-I ELISA | Diagnostic Systems Laboratories, Inc. | 1995-05-10 | Traditional | PDF ↗ |
| K951707 | DSL ACTIVE IFGBP-3 ELISA | Diagnostic Systems Laboratories, Inc. | 1995-05-10 | Traditional | PDF ↗ |
| K950510 | OCTEIA IGF-1 KIT | Immunodiagnostic Systems , Ltd. | 1995-04-05 | Traditional | PDF ↗ |
| K950228 | DSL ACTIVE IGFBP-3 IRMA (DSL 6600) | Diagnostic Systems Laboratories, Inc. | 1995-02-22 | Traditional | PDF ↗ |
| K930047 | DSL IGFBP-3 RIA (DSL 6700) | Diagnostic Systems Laboratories, Inc. | 1994-07-06 | Traditional | PDF ↗ |
| K921868 | ENDOCRINE SCIENCES PRODUCTS IGFBP3 RADIOIMMUNO KIT | Endocrine Sciences Products | 1994-01-03 | Traditional | PDF ↗ |
| K930484 | DELFIA(R) HGH KIT | Wallac OY | 1993-05-11 | Traditional | PDF ↗ |
| K920299 | MEDIX BIOTECH HGHENZYME IMMUNOASSAY TEST KIT | Medix Biotech, Inc. | 1992-03-04 | Traditional | PDF ↗ |
| K912858 | LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY | London Diagnostics, Inc. | 1991-07-30 | Traditional | PDF ↗ |
| K905757 | AIA-PACK HGH | Tosoh Medics, Inc. | 1991-01-25 | Traditional | PDF ↗ |
| K905098 | ELEGANCE GH ELISA | Bioclone Australia Pty , Ltd. | 1990-12-06 | Traditional | PDF ↗ |
| K896808 | IGF-I BY EXTRACTION; INSULIN-LIKE GROWTH FACTOR I | Nichols Institute Diagnostics | 1990-01-19 | Traditional | PDF ↗ |
| K896643 | HUMAN GROWTH HORMONE ENZYME IMMUNOASSAY MB-1015 | Medix Biotech, Inc. | 1989-12-29 | Traditional | PDF ↗ |
| K882823 | FIAGEN HGH FLUOROIMMUNOASSAY KIT | Cyberfluor, Inc. | 1988-08-30 | Traditional | PDF ↗ |
| K875229 | DSL SOMATOMEDIN-C (DSL #5600) | Diagnostic Systems Laboratories, Inc. | 1988-07-01 | Traditional | PDF ↗ |
| K860228 | SUCROSEP HUMAN GROWTH HORMONE (HGH) IRMA | Boots-Celltech Diagnostics, Inc. | 1986-02-28 | Traditional | PDF ↗ |
| K852299 | TERUMO SENSIBEAD EIA HGH KIT | Terumo Medical Corp. | 1985-07-09 | Traditional | PDF ↗ |
| K850892 | SOMATOMEDIN C BY RADIOIMMUNOASSAY | Immuno Nuclear Corp. | 1985-06-06 | Traditional | PDF ↗ |
| K851259 | HUMAN GROWTH HORMONE IMMUNORADIOMETRIC ASSAY KIT | Nichols Institute Diagnostics | 1985-05-13 | Traditional | PDF ↗ |
| K841088 | SOMATOMEDIN-C RADIOIMMUNOASSAY KIT | Nichols Institute Diagnostics | 1984-10-22 | Traditional | PDF ↗ |
| K841094 | HUMAN GROWTH HORMONE RIA KIT | Diagnostic Products Corp. | 1984-05-07 | Traditional | PDF ↗ |
| K831073 | DAC-CEL HCG-MCA KIT RD52 | Wellcome Diagnostics | 1983-09-01 | Traditional | PDF ↗ |
| K821366 | TANDEM - HGH KIT | Hybritech, Inc. | 1982-06-10 | Traditional | PDF ↗ |
| K803280 | HUMAN GROWTH HORMONE-RADIOIMM. KIT | Immuno Nuclear Corp. | 1981-01-16 | Traditional | PDF ↗ |
| K780347 | RIA SYS. FOR HUMAN GROWTH HORMONE | Calbiochem-Behring Corp. | 1978-04-12 | Traditional | PDF ↗ |
Product code CFL · Class I · Clinical Chemistry. Data: openFDA.