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

Microbiological Research Corp. — Predicate Candidate Screening

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

98 daysmedian FDA review time

314 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days
K883011	MRI NEO-TRYP TRYPSIN RIA	Microbiological Research Corp.	1989-04-26	281
K861121	THE GOLDEN QUAD TEST (EBV)	Microbiological Research Corp.	1987-02-02	314
K861122	THE GOLDEN QUAD TEST (TOXO)	Microbiological Research Corp.	1987-02-02	314
K861120	THE GOLDEN QUAD TEST (HSV)	Microbiological Research Corp.	1987-02-02	314
K861123	THE GOLDEN QUAD TEST (CMV)	Microbiological Research Corp.	1987-02-02	314
K860450	THE CMV-IGM TEST	Microbiological Research Corp.	1986-05-13	98
K843138	CMV TEST	Microbiological Research Corp.	1985-01-29	173
K821018	ANTIHUMAN IGG GLOBULIN FITC LABELED	Microbiological Research Corp.	1982-04-29	17
K821019	PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU	Microbiological Research Corp.	1982-04-26	14
K803133	RUBELLA VIRUS SEROLOGICAL REAGENT RUBEL	Microbiological Research Corp.	1981-01-29	48
K803175	RUBELLA VIRUS SEROLOGICAL REAGENTS	Microbiological Research Corp.	1981-01-29	45
K803134	TOXOPLASMA GONDII SEROLOGICAL REAGENTS	Microbiological Research Corp.	1981-01-29	48
K803132	HERPES SIMPLEX VIRUS SEROLOGICAL REAGENT	Microbiological Research Corp.	1981-01-28	47
K770092	HERPESIVIRUS TEST (TYPE L & 2)	Microbiological Research Corp.	1977-03-01	43

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