Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Nichols Institute · Predicate Candidate Screening

15 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

105 daysmedian FDA review time
282 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K952559ERYTHROPOIETIN IMMUNOASSAY KITNichols Institute1996-05-293620
K952505INSULIN-LIKE GROWTH FACTOR I (IGF-I), IMMUNORADIOMETERIC ASSNichols Institute1995-07-03330
K946247IGFBP-3; INSULIN-LIKE GROWTH FACTOR BINDING PROTEIN-3Nichols Institute1995-06-231830
K950524NICHOLS INSTITUTE DIAGNOSTICS DHEA-S CHEMILUMINESCENCE IMMUNNichols Institute1995-05-151050
K932650ERYTHROPOIETIN IMMUNOASSAY KITNichols Institute1994-03-112820
K931600CHEMILUMINESCENCE FREE T3 IMMUNOASSAYNichols Institute1993-09-081600
K931777APO A-1 CHEMILUMINESCENCE ASSAYNichols Institute1993-08-161290
K931601CHEMILUMINESCENCE DHEA-S IMMUNOASSAYNichols Institute1993-07-271170
K926396ADRENOCORTICOTROPIC/ACTH ANALYSIS PRODUCTNichols Institute1993-07-272180
K931311THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KITNichols Institute1993-05-14600
K930777THYROGLOBULIN AUTOANTIBODY IMMUNOASSAY KITNichols Institute1993-04-08510
K924675TSH - THIRD GENERATION LOW CONTROLSNichols Institute1992-11-18630
K922676CORTISOL CHEMILUMINESCENCE ASSAYNichols Institute1992-07-10360
K920300B2-MICROGLOBULIN RADIOIMMUNOASSAYNichols Institute1992-03-17550
K903391ALLEGRO LITE THYROID STIMULATING HORMONE CHEM. IMMNichols Institute1990-10-12770

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda