Atlas FDA

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

Immuchem Corp. — Predicate Candidate Screening

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

37 daysmedian FDA review time
106 days90th percentile
18clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K883726THYROID STIMULATING HORMONE (HTSH) IRMA NEONATALImmuchem Corp.1988-12-151060
K871317FOLLICLE STIMULATING HORMONE (HFSH)Immuchem Corp.1987-05-20480
K871542HPROLACTIN KITImmuchem Corp.1987-05-14240
K865071THYROID STIMULATING HORMONE (TSH IRMA) RIA KITImmuchem Corp.1987-03-13740
K864144LUTEINIZING HORMONE (LH-IRMA) RIA KITImmuchem Corp.1986-11-24330
K860559ANDROSTENEDIONE 125I KIT BY RIAImmuchem Corp.1986-03-14280
K854094IMMUCHEM COVALENT COAT A SOLID PHASE RADIOIMMUNOASImmuchem Corp.1986-02-281440
K830962IMMUCHEM COVALENT-COAT RIA KITImmuchem Corp.1983-05-04370
K822509COVALENT COAT RIA KITImmuchem Corp.1982-09-28390
K822140IMMUCHEM COVALENT-COATImmuchem Corp.1982-08-05160
K820329ESTRADIOL KIT BY RIAImmuchem Corp.1982-03-04240
K813484PROGESTERONE KIT BY RIAImmuchem Corp.1981-12-22210
K811536DIRECT TESTOSTERONE RIAImmuchem Corp.1981-06-18170
K811398EARLY PREGNANCY DETECTIONImmuchem Corp.1981-05-29110
K801666TESTOSTERONE KITImmuchem Corp.1980-08-27370
K791663IMMUCHEM COVALENT COAT SOLID PHASE ASSAYImmuchem Corp.1979-10-01410
K791662IMMUCHEM COVALENT COAT BINDINGImmuchem Corp.1979-09-27370
K791664IMMUCHEM COVALENT COAT SOLID PHASE ASSAYImmuchem Corp.1979-09-27370

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