Company ยท US
Nichols Institute
FDA 510(k) clearances and medical device recalls filed under this name, 1990 to 1996. Name variants (Inc, Corp, punctuation) are merged.
15510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CFL | Radioimmunoassay, Human Growth Hormone | 2 |
| GGT | Assay, Erythropoietin | 2 |
| JKC | Radioimmunoassay, Dehydroepiandrosterone (Free And Sulfate) | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CGR | Radioimmunoassay, Cortisol | 1 |
| CKG | Radioimmunoassay, Acth | 1 |
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | 1 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 1 |
| JNL | Immunochemical, Thyroglobulin Autoantibody | 1 |
| JZG | System, Test, Beta-2-Microglobulin Immunological | 1 |
| JZO | System, Test, Thyroid Autoantibody | 1 |
| MSJ | Apolipoproteins | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| May 29, 1996 | K952559 | ERYTHROPOIETIN IMMUNOASSAY KIT Nichols Institute | GGT |
| Jul 3, 1995 | K952505 | INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSAY (IRMA) Nichols Institute | CFL |
| Jun 23, 1995 | K946247 | IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3 Nichols Institute | CFL |
| May 15, 1995 | K950524 | NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNOASSAY Nichols Institute | JKC |
| Mar 11, 1994 | K932650 | ERYTHROPOIETIN IMMUNOASSAY KIT Nichols Institute | GGT |
| Sep 8, 1993 | K931600 | CHEMILUMINESCENCE FREE T3 IMMUNOASSAY Nichols Institute | CDP |
| Aug 16, 1993 | K931777 | APO A-1 CHEMILUMINESCENCE ASSAY Nichols Institute | MSJ |
| Jul 27, 1993 | K931601 | CHEMILUMINESCENCE DHEA-S IMMUNOASSAY Nichols Institute | JKC |
| Jul 27, 1993 | K926396 | ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCT Nichols Institute | CKG |
| May 14, 1993 | K931311 | THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT Nichols Institute | JZO |
| Apr 8, 1993 | K930777 | THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KIT Nichols Institute | JNL |
| Nov 18, 1992 | K924675 | TSH - THIRD GENERATION LOW CONTROLS Nichols Institute | JJX |
| Jul 10, 1992 | K922676 | CORTISOL CHEMILUMINESCENCE ASSAY Nichols Institute | CGR |
| Mar 17, 1992 | K920300 | B2-MICROGLOBULIN RADIOIMMUNOASSAY Nichols Institute | JZG |
| Oct 12, 1990 | K903391 | ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMM Nichols Institute | JLW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||