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

Ab Biodisk — Predicate Candidate Screening

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

78 daysmedian FDA review time

123 days90th percentile

64clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K081325	ETEST DORIPENEM - ANTIMICROBIAL SUSCEPTIBILITY TEST - MIC AT	Ab Biodisk	2008-07-24	73	1
K052366	ETEST TIGECYCLINE GRAM POSITIVE AND GRAM NEGATIVE AEROBIC BA	Ab Biodisk	2005-10-13	45	0
K042392	DAPTOMYCIN	Ab Biodisk	2004-12-13	102	0
K042390	ETEST FOR GEMIFLOXACIN	Ab Biodisk	2004-11-19	78	0
K040560	ETEST FOR ANTIFUNGAL SUSCEPTTIBILITY TESTING	Ab Biodisk	2004-07-27	146	1
K021445	ETEST CEFDITOREN FOR S. PNEUMONIAE AND H. INFLUENZAE	Ab Biodisk	2002-06-06	31	0
K020748	ETEST ERTAPENEM	Ab Biodisk	2002-04-29	53	2
K010363	ETEST MEROPENEM	Ab Biodisk	2001-04-09	61	2
K002139	ETEST LINEZOLID	Ab Biodisk	2000-11-08	114	0
K001547	ETEST ESBL CT/CTL STRIP; ETEST ESBL TZ/TZL STRIP	Ab Biodisk	2000-08-07	81	0
K000596	ETEST GATIFLOXACIN	Ab Biodisk	2000-05-22	90	0
K000298	ETEST MOXIFLOXACIN	Ab Biodisk	2000-05-18	108	0
K992993	ETEST FOR QUINUPRISTIN/DALFOPRISTIN	Ab Biodisk	1999-11-16	70	0
K990722	ETEST FOR CEFUROXIME	Ab Biodisk	1999-04-22	48	0
K990685	TRIMETHOPRIM/SULPHAMETHOXAZOLE (1/19)	Ab Biodisk	1999-03-26	23	0
K990297	ETEST MINOCYCLINE	Ab Biodisk	1999-03-22	52	1
K984491	SYSTEM U3 FOR CEFUROXIME	Ab Biodisk	1999-03-09	82	0
K984581	SYSTEM U3 FOR CEPHALOTHIN	Ab Biodisk	1999-03-09	76	0
K983890	SYSTEM U3	Ab Biodisk	1999-02-18	108	0
K984144	SYSTEM U3 FOR AMOXICILLIN/CLAVULANIC ACID	Ab Biodisk	1999-02-09	83	0
K984087	SYSTEM U3 FOR AMPICILLIN	Ab Biodisk	1999-02-08	84	0
K983565	SYSTEM U3 FOR NITROFURANTOIN	Ab Biodisk	1999-01-05	84	0
K983571	SYSTEM U3 FOR TETRACYCLINE	Ab Biodisk	1998-12-30	78	0
K983486	SYSTEM U3 FOR NORFLOXACIN	Ab Biodisk	1998-12-23	79	0
K983259	SYSTEM U3 FOR TRIMETHOPRIM/SULFAMETHOXAZOLE	Ab Biodisk	1998-11-25	70	0
K983027	TRIMETHOPRIM/SULPHAMETHOXAZOLE	Ab Biodisk	1998-10-02	32	0
K982868	ETEST RIFAMPICIN WITH INDICATIONS FOR S. PNEUMONIAE	Ab Biodisk	1998-09-30	47	1
K981639	SYSTEM U3 FOR CIPROFLOXACIN	Ab Biodisk	1998-09-03	118	0
K980877	ETEST CEFDINIR	Ab Biodisk	1998-07-06	119	0
K980335	ETEST BENZYLPENICILLIN	Ab Biodisk	1998-06-15	138	0
K981135	ETEST BENZYLPENICILLIN	Ab Biodisk	1998-06-09	71	2
K981137	ETEST CEFOTAXIME	Ab Biodisk	1998-06-09	71	1
K981136	ETEST FOSFOMYCIN	Ab Biodisk	1998-06-09	71	1
K981138	ETEST CIPROFLOXACIN	Ab Biodisk	1998-06-05	67	1
K981139	ETEST CEFTRIAXONE	Ab Biodisk	1998-06-01	63	1
K980342	ETEST CHLORAMPHENICAL	Ab Biodisk	1998-05-29	121	0
K980348	ETEST VANCOMYCIN	Ab Biodisk	1998-05-29	121	3
K981134	ETEST TETRACYCLINE	Ab Biodisk	1998-05-28	59	0
K980338	ETEST OFLOXACIN	Ab Biodisk	1998-05-28	120	0
K980347	ETEST TETRACYCLINE	Ab Biodisk	1998-05-27	119	0
K980345	ETEST CEFTRIAXONE	Ab Biodisk	1998-05-27	118	2
K980773	ETEST GREPAFLOXACIN	Ab Biodisk	1998-05-18	77	0
K980603	ETEST TROVAFLOXACIN	Ab Biodisk	1998-05-13	85	0
K971697	ETEST FOR LEVOFLOXACIN	Ab Biodisk	1997-07-14	67	1
K971694	ETEST FOR CEFTAZIDIME	Ab Biodisk	1997-06-30	54	1
K970473	ETEST SUBMISSION FOR AZITHROMYCIN/S. PNEUMONIAE	Ab Biodisk	1997-05-01	83	0
K964236	(MODIFIED) ETEST PACKAGE INSERT	Ab Biodisk	1997-05-01	195	0
K970210	AMIKACIN	Ab Biodisk	1997-05-01	100	1
K970820	ETEST SPARFLOXACIN	Ab Biodisk	1997-04-25	50	0
K964203	PIPERACILLIN/TAZOBACTAM 4	Ab Biodisk	1996-12-18	77	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