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

Remel Co. — Predicate Candidate Screening

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

51 daysmedian FDA review time

108 days90th percentile

137clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K013711	BACTI-SWAB DRY	Remel Co.	2001-11-26	19	0
K965149	A.C.T. I	Remel Co.	1997-01-22	30	0
K965152	A.C.T. II	Remel Co.	1997-01-22	30	1
K965151	A.C.T. III	Remel Co.	1997-01-22	30	0
K965150	A.C.T. IV	Remel Co.	1997-01-22	30	0
K960095	BACTIDROP CALCOFLUOR WHITE	Remel Co.	1996-03-19	68	0
K960090	CALCOFLUOR WHITE STAIN KIT	Remel Co.	1996-03-19	68	0
K955669	REMEL CEFEPIME 30 UG SUSCEPTIBILITY DISK	Remel Co.	1996-02-23	72	0
K941444	BHI AGAR WITH VANCOMYCIN	Remel Co.	1994-09-19	179	0
K941443	SYNERGY QUAD	Remel Co.	1994-09-19	179	0
K936021	BACTICARD STREP	Remel Co.	1994-05-20	154	0
K933457	RIM E.COLI 0157:H7 LATEX TEST	Remel Co.	1994-04-20	280	0
K935124	BACTICARD CANDIDA	Remel Co.	1994-02-25	120	0
K934986	BACTICARD E. COLI	Remel Co.	1994-02-23	127	0
K934100	REMEL CEFPROZIL 30 MCG SUSCEPTIBILITY DISK	Remel Co.	1993-11-22	91	0
K933514	BACTICARD STREP	Remel Co.	1993-10-28	100	0
K933657	REMEL AZITHROMLYCIN 15 MCG SUSCEPTIBILITY DISK	Remel Co.	1993-10-28	93	0
K933118	REMEL CLARITHROMYCIN 15 MCG SUSCEPTIBILITY DISK	Remel Co.	1993-08-10	46	0
K931383	ZINC PVA	Remel Co.	1993-06-15	89	0
K931799	REMEL LORACARBEF 30 MCG SUSCEPTIBILITY DISK	Remel Co.	1993-06-15	64	0
K931289	REMEL CEFPODOXIME 10 MCG SUSCEPTIBILITY DISK	Remel Co.	1993-06-02	82	0
K931290	REMEL CEFMETAZOLE 30 MCG SUSCEPTIBILITY DISK	Remel Co.	1993-05-20	69	0
K930878	BACTIDROP(TM) MUCAP	Remel Co.	1993-05-11	81	0
K925060	REMEL ENOXACIN 10 MCG SUSCEPTIBILITY DISK	Remel Co.	1992-12-03	58	0
K924846	REMEL CEFACLOR 30MCG SUSCEPTIBILITY DISK	Remel Co.	1992-11-30	63	0
K923566	NIZYME TEST KIT	Remel Co.	1992-11-02	108	0
K924765	REMEL LOMEFLOXACIN 10 MCG SUSCEPTIBILITY DISK	Remel Co.	1992-10-26	33	0
K924766	REMEL OFLOXACIN 5MCG SUSCEPTIBILITY DISK	Remel Co.	1992-10-26	33	0
K923700	INDOXYL ACETATE DISK	Remel Co.	1992-10-05	73	0
K923827	LAP DISK	Remel Co.	1992-09-28	60	0
K920973	BACTIDROP INDOLE (ERLICH'S)	Remel Co.	1992-06-19	109	0
K920974	BACTIDROP ACRIDINE ORANGE	Remel Co.	1992-06-19	109	1
K920976	BACTIDROP INDIA INK	Remel Co.	1992-06-09	99	0
K920975	BACTIDROP CALCOFLUOR WHITE	Remel Co.	1992-06-09	99	0
K920143	TB SUSCEPTIBILITY QUADS I AND II	Remel Co.	1992-06-09	148	0
K920970	BACTIDROP KOH (10%)	Remel Co.	1992-06-09	99	0
K920971	BACTIDROP NINHYDRIN	Remel Co.	1992-05-22	81	0
K920972	BACTIDROP PYR	Remel Co.	1992-05-22	81	0
K920257	NIACIN CONTROL DISKS	Remel Co.	1992-04-22	92	0
K913007	BACTIDROP(TM) VOGES-PROSKAUER B	Remel Co.	1991-09-23	77	0
K913002	BACTIDROP(TM) FERRIC CHLORIDE (10%)	Remel Co.	1991-09-23	77	0
K913006	BACTIDROP(TM) DOBELL & O'CONNOR IODINE	Remel Co.	1991-09-23	77	0
K913008	BACTIDROP(TM) OXIDASE	Remel Co.	1991-09-23	77	0
K913003	BACTIDROP(TM) VOGES-PROSKAUER A	Remel Co.	1991-09-23	77	0
K913011	BACTIDROP(TM) NITRATE A	Remel Co.	1991-09-19	73	0
K913010	BACTIDROP (TM) NITRATE B	Remel Co.	1991-09-19	73	0
K913009	BACTIDROP(TM) INDOLE (KOVACS)	Remel Co.	1991-09-18	72	0
K913001	BACTIDROP(TM) DESOXYCHOLATE (10%)	Remel Co.	1991-09-18	72	0
K913004	BACTIDROP(TM) SPOT INDOLE	Remel Co.	1991-09-18	72	0
K913005	BACTIDROP(TM) LACTOPHENOL ANILINE BLUE	Remel Co.	1991-09-16	70	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