Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

Isolab, Inc. — Predicate Candidate Screening

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

92 daysmedian FDA review time

277 days90th percentile

44clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K951014	ISOLAB'S T4 TEST KIT	Isolab, Inc.	1996-10-18	592	0
K950481	NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT	Isolab, Inc.	1996-02-01	363	5
K943547	PHENYLALANINE TEST KIT	Isolab, Inc.	1996-01-26	554	0
K950803	ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 8	Isolab, Inc.	1995-09-21	212	2
K950415	FLUOROSCAN NEONATAL	Isolab, Inc.	1995-09-05	217	0
K942222	QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS	Isolab, Inc.	1995-01-20	259	0
K942276	QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY	Isolab, Inc.	1995-01-20	255	0
K944185	ISOSCAN	Isolab, Inc.	1994-11-17	83	0
K934013	RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT	Isolab, Inc.	1994-04-26	251	0
K923153	HEMOCARD, HEMOGLOBIN C ASSAY	Isolab, Inc.	1994-01-27	577	0
K931234	HEMOCARD CONTROL HB-AA, AE, FAA, FAE	Isolab, Inc.	1993-05-11	62	0
K930070	HEMOCARD HEMOGLOBIN E	Isolab, Inc.	1993-04-08	92	0
K924173	HEMOCARD(TM) CONTROL	Isolab, Inc.	1992-12-01	104	0
K921681	CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL	Isolab, Inc.	1992-11-17	223	0
K911981	HEMOCARD HEMOGLOBIN S	Isolab, Inc.	1991-10-09	159	0
K910430	HEMOCARD-AS	Isolab, Inc.	1991-04-15	73	0
K910431	HEMOCARD CONTROL	Isolab, Inc.	1991-03-11	38	0
K905513	GLYC-AFFIN(TM)-GA	Isolab, Inc.	1991-01-15	36	0
K904814	GLYC-AFFIN GP	Isolab, Inc.	1990-12-26	63	0
K902740	LDL-DIRECT CONTROLS	Isolab, Inc.	1990-12-07	168	0
K901453	QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD	Isolab, Inc.	1990-04-12	16	0
K883411	PG-NUMERIC(TM)	Isolab, Inc.	1989-03-15	212	0
K880673	GHB SAMPLE PAPER	Isolab, Inc.	1988-11-22	277	0
K873428	GLYCO-PROBE GSP	Isolab, Inc.	1988-04-05	224	0
K862638	VISIBLE-CHLAMYDIA(TM) TEST SYSTEM	Isolab, Inc.	1986-08-26	47	0
K854712	VISIBLE-HERPES TM TEST SYSTEM	Isolab, Inc.	1986-05-20	179	0
K843122	RESOLVE-CSF	Isolab, Inc.	1984-11-30	114	1
K842152	SICKLING HEMOGLOBIN CONTROLS, NORMAL	Isolab, Inc.	1984-09-09	102	0
K841170	SICKLE HB ASSAY	Isolab, Inc.	1984-04-04	16	0
K840011	RESOLVE-HB	Isolab, Inc.	1984-02-04	31	2
K830606	QUIK-SEP IGM ISOLATION SYSTEM	Isolab, Inc.	1983-03-24	27	0
K822867	GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY	Isolab, Inc.	1982-12-03	67	0
K820630	QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL	Isolab, Inc.	1982-06-25	109	0
K812318	LIPO-SEP CHOLESTEROL AUDIT SYSTEM	Isolab, Inc.	1981-09-01	15	0
K810976	ALPHA-THAL SCREEN TM CONTROL	Isolab, Inc.	1981-05-29	49	0
K810919	HEMOGLOBIN ELECTROPHORESIS CONTROL	Isolab, Inc.	1981-04-23	17	0
K801771	ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT	Isolab, Inc.	1981-01-16	172	0
K802997	HDL-CHOLESTEROL CONTROL SERUM	Isolab, Inc.	1980-12-22	27	0
K801410	HEMOHLOBIN A2 CONTROL-LYOPHILIZED	Isolab, Inc.	1980-07-21	35	0
K800794	FAST HEMOGLOBIN CONTROL-LYOPHILIZED	Isolab, Inc.	1980-04-29	20	0
K791143	SICKLE-CELL F TEST	Isolab, Inc.	1979-07-17	29	0
K781851	HEMOGLOBIN, TESTING SYSTEM	Isolab, Inc.	1978-11-07	4	0
K780998	SCALPEL	Isolab, Inc.	1978-07-27	43	0
K771649	HEMOGLOBIN A2 TESTING SYSTEM	Isolab, Inc.	1977-10-07	39	0

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