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

Meloy Laboratories, Inc. — Predicate Candidate Screening

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

37 daysmedian FDA review time
87 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K852033SS-A(RO) & SS-B(LA) ANTIBODY ASSAYMeloy Laboratories, Inc.1985-06-21430
K844678MELOY LAB-ANTINUCLEAR ANTIBODY TEST-HEP-2 CELL CULMeloy Laboratories, Inc.1985-01-04350
K841708MELOY IMMUNOSTAT MONOCLONAL FACTOR VIIIMeloy Laboratories, Inc.1984-07-19870
K842247MELOY AUTOANTIBODY TEST SYSMeloy Laboratories, Inc.1984-06-26200
K831292ANTI-ENA TESTMeloy Laboratories, Inc.1983-07-18890
K820265ANA TEST (MOUSE LIVER SUBSTRATE)Meloy Laboratories, Inc.1982-02-12100
K820005TOTAL HEMOLYTIC COMPLEMENT TEST KITMeloy Laboratories, Inc.1982-01-22180
K811178HUMAN IGG-ALBUMIN TEST KITMeloy Laboratories, Inc.1981-05-15170
K792562IMMUNOSTAT TSH TESTMeloy Laboratories, Inc.1980-01-16350
K791493ANTI-NUCLEAR ANTIBODY TESTMeloy Laboratories, Inc.1979-09-24530
K791065IMMUNOSPOT TSH TESTMeloy Laboratories, Inc.1979-07-30480
K790252ANTI-NATIVE DEOXYRIB-ONUCLEIC ACID ANTIMeloy Laboratories, Inc.1979-03-15370
K771606IMMUNOSPOT NEONATAL T4 TESTMeloy Laboratories, Inc.1977-09-15240
K771382IMMUNOSTAT T3 UPTAKE TESTMeloy Laboratories, Inc.1977-09-02380
K771155ANTI-MITOCHONDRIALMeloy Laboratories, Inc.1977-08-04370

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