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KIT — Predicate Candidate Screening

367 FDA 510(k) clearances under this product code; the 50 most recent screened below.

20 daysmedian FDA review time

51 days90th percentile

367clearances measured

K-number	Device	Applicant	Decided	Review days
K892938	AMNIO-GROW TM	Inovar Biologicals, Inc.	1989-05-22	31
K890701	ENDOTHELIAL GROWTH MEDIUM (EGM)	Clonetics Corp.	1989-02-24	14
K890700	MELANOCYTE GROWTH MEDIUM (MGM)	Clonetics Corp.	1989-02-24	14
K890482	ABC, ABC-1X, ABC(TM)	Cell Ent., Inc.	1989-02-10	10
K884654	ALPHACALF SERUM	Hyclone Laboratories, Inc.	1988-11-30	23
K884573	HBSS W/O CALC CHLOR/MAG SULF/PHEN RED/SB NO. H4891	Sigma Chemical Co.	1988-11-22	21
K884572	RPMI-1640 HYBRI-MAX, PROD. NO. R5382	Sigma Chemical Co.	1988-11-22	21
K884574	DME & HAM'S NUTRIENT MIXTURE, PROD. NO. D9785	Sigma Chemical Co.	1988-11-22	21
K883065	ALLOPREP SYSTEM	Osteotech, Inc.	1988-10-13	85
K884031	FBS, EQ., OR FETAL BOVINE SERUM EQUIVALENT	Regency Biotech	1988-10-06	13
K883951	MEDIUM 199 W/EBSS (CATALOG NO. 200-2037)	J R Scientific	1988-09-30	11
K883682	CHANG MEDIUM (ADDITIONAL INDICATIONS)	Hana Biologics, Inc.	1988-09-16	18
K883625	EX-CELL 301, CATALOG NO. 200-3651	J R Scientific	1988-09-07	16
K883624	EX-CELL 300TM, CATALOG NO. 200-3601	J R Scientific	1988-09-07	16
K883628	MIN ESSENT MED EAGLE FOR SPINN CULTURE, #200-2051	J R Scientific	1988-09-07	16
K883627	MIN ESSENT MED EAGLE, JOKLIK MOD, CAT. #200-2150	J R Scientific	1988-09-07	16
K883629	HANK'S BALANCED SALTS (HBSS) CATALOG # 210-3013	J R Scientific	1988-09-07	16
K883631	EX-CELL 300TM, CATALOG # 210-3579	J R Scientific	1988-09-07	16
K883623	EX-CELL 300TM, CATALOG NO. 200-3600	J R Scientific	1988-09-07	16
K883632	EX-CELL 300TM, CATALOG NO. 210-3575	J R Scientific	1988-09-07	16
K883626	EX-CELL 301, CATALOG NO. 210-3577	J R Scientific	1988-09-07	16
K883630	RPMI-1640 MEDIUM, CATALOG NO. 210-3525	J R Scientific	1988-09-07	16
K883451	SFRE 199-1 MEDIUM, CATALOG NO. 200-2191	J R Scientific	1988-08-30	15
K883362	L-15 MEDIUM, CATALOG NO. 200-2021	J R Scientific	1988-08-29	20
K883369	L-15 MEDIUM, CATALOG NO. 210-4004	J R Scientific	1988-08-29	20
K883370	FISCHER'S MEDIUM CATALOG NO. 210-4007	J R Scientific	1988-08-29	20
K883363	ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.200-2105	J R Scientific	1988-08-29	20
K883364	ISCOVE'S MODIFIED DELBECCO'S MEDIUM NO.210-3505	J R Scientific	1988-08-29	20
K883449	MINIMUM ESSENTIAL MEDIUM EAGLE, NO. 200-2048	J R Scientific	1988-08-29	14
K883367	CALF SERUM, CATALOG NO. 110-1125	J R Scientific	1988-08-29	20
K883445	HANKS' BALANCED SALTS (HBSS) 10X, NO. 210-3012	J R Scientific	1988-08-29	14
K883496	MINIMUM ESSENTIAL MEDIUM EAGLE (MEM), 210-3517	J R Scientific	1988-08-29	13
K883501	MCCOY'S 5A MEDIUM (CATALOG NO. 210-3531)	J R Scientific	1988-08-29	13
K883502	FETAL BOVINE SERUM, DEFINED NO. 110-1121	J R Scientific	1988-08-29	13
K883448	MINIMUM ESSENTIAL MEDIUM EAGLE NO. 200-2046	J R Scientific	1988-08-29	14
K883498	FETAL BOVINE SERUM, HEAT INACTIVATED NO.110-1123	J R Scientific	1988-08-29	13
K883446	FETAL BOVINE SERUM, GAMMA IRRADIATED NO. 110-1122	J R Scientific	1988-08-29	14
K883497	MEDIUM 199, 10X CATALOG NO. 210-3556	J R Scientific	1988-08-29	13
K883365	HORSE SERUM, ABATTOIR, NO. 110-1112	J R Scientific	1988-08-29	20
K883499	MEDIUM 199, 10X, CATALOG NO. 210-3557	J R Scientific	1988-08-29	13
K883500	MCCOY'S 5A MEDIUM 10X NO. 210-3532	J R Scientific	1988-08-29	13
K883450	SFRE 199-2 MEDIUM, CATALOG NO. 200-2192	J R Scientific	1988-08-29	14
K883495	MEDIUM 199, 10X, CATALOG NO. 210-3555	J R Scientific	1988-08-29	13
K883368	NEWBORN CALF SERUM, CATALOG NO. 110-1130	J R Scientific	1988-08-29	20
K883366	MEDIUM 199, CATALOG NO. 200-2031	J R Scientific	1988-08-29	20
K883447	MINIMUM ESSENTIAL MEDIUM EAGLE 10X, NO.210-3511	J R Scientific	1988-08-29	14
K883291	DONOR HORSE SERUM, CAT. NO. 110-1110	J R Scientific	1988-08-15	11
K883138	CMRL 1969 MAINTENANCE MEDIUM CAT, # 200-2177	J R Scientific	1988-08-15	20
K883141	RPMI-1640 W/25MM HEPES BUFF W/O SOD BICAR 200-2120	J R Scientific	1988-08-15	20
K883286	NEWBORN CALF SERUM, HEAT INACTIVATED # 110-1131	J R Scientific	1988-08-15	11

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