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

Dade Microscan, Inc. — Predicate Candidate Screening

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

65 daysmedian FDA review time

230 days90th percentile

40clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K043589	MICROSCAN DRIED GRAM-POSITIVE MIC/COMBO PANELS - ERTAPENEM	Dade Microscan, Inc.	2005-02-14	48	0
K023202	MICROSCAN SYNERGIES PLUS	Dade Microscan, Inc.	2002-10-23	28	0
K021184	MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CLINDAMYCI	Dade Microscan, Inc.	2002-06-20	66	0
K021181	MICROSCAN MICROSTREP PLUS PANEL NEW ANTICROBIAL-CLARITHROMYC	Dade Microscan, Inc.	2002-06-17	63	0
K021018	MICROSCAN MICROSTREP PLUS PANEL - CHLORAMPHENICOL	Dade Microscan, Inc.	2002-06-11	74	0
K021078	MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-ERYTHROMYC	Dade Microscan, Inc.	2002-06-06	64	0
K021111	MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFOTAXI	Dade Microscan, Inc.	2002-06-06	62	0
K021169	MICROSTREP PLUS PANEL, AZITHROMYCIN	Dade Microscan, Inc.	2002-06-06	56	0
K021110	MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL- CEFTRIAXO	Dade Microscan, Inc.	2002-06-06	62	0
K021188	MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-CEFEPIME	Dade Microscan, Inc.	2002-06-06	52	0
K020938	MICROSCAN MICROSTREP PLUS PANEL-MEROPENEM	Dade Microscan, Inc.	2002-06-03	73	0
K020939	MICROSCAN MICROSTREP PLUS PANEL-TETRACYCLINE	Dade Microscan, Inc.	2002-05-17	56	0
K020937	MICROSCAN MICROSTREP PLUS PANEL-AMOXICILLIN/CLAVULANIC ACID	Dade Microscan, Inc.	2002-05-06	45	0
K020627	MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-GATIFLOXAC	Dade Microscan, Inc.	2002-05-06	69	0
K020691	MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - CEFACLOR	Dade Microscan, Inc.	2002-04-30	57	0
K020686	MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL - TRIMETHO	Dade Microscan, Inc.	2002-04-30	57	0
K020626	MICROSCAN MICROSTREP PLUS PANEL NEW ANTIMICROBIAL-PENICILLIN	Dade Microscan, Inc.	2002-04-26	59	2
K020556	MICROSCAN MICROSTREP PLUS PANEL WITH LEVOFLOXACIN	Dade Microscan, Inc.	2002-04-26	65	0
K020506	MICROSCAN SYNERGIES PLUS GRAM-NEGATIVE MIC/COMBO PANELS WITH	Dade Microscan, Inc.	2002-04-17	61	0
K020037	DRIED GRAM NEGATIVE MIC/COMBO PANELS	Dade Microscan, Inc.	2002-03-22	77	0
K020511	MICROSCAN SYNERGIES PLUS	Dade Microscan, Inc.	2002-03-06	19	0
K013423	MICROSCAN DRIED GRAM NEGATIVE OVERNIGHT MIC/COMBO PANELS	Dade Microscan, Inc.	2001-12-12	71	0
K010159	DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS	Dade Microscan, Inc.	2001-07-27	191	0
K003619	DRIED GRAM-POSITIVE MIC/COMBO PANELS	Dade Microscan, Inc.	2001-01-09	48	0
K983943	MICROSTREP PLUS PANEL, LEVOFLOXACIN	Dade Microscan, Inc.	2000-02-18	470	0
K993679	MICROSTREP PLUS PANEL - HAEMOPHILUS/AMPICILLIN	Dade Microscan, Inc.	2000-01-14	74	0
K983953	MICROSTREP PLUS PANEL, VANCOMYCIN	Dade Microscan, Inc.	2000-01-14	435	0
K983746	MICROSTREP PLUS PANEL	Dade Microscan, Inc.	1999-12-09	412	0
K993102	DRIED GRAM-POSITIVE MIC/COMBO PANELS	Dade Microscan, Inc.	1999-12-02	77	0
K983922	DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS	Dade Microscan, Inc.	1999-06-17	225	0
K983408	DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS	Dade Microscan, Inc.	1999-05-10	224	0
K983711	DRIED GRAM-NEGATIVE AND GRAM-POSITIVE MIC/COMBO PANELS	Dade Microscan, Inc.	1999-04-27	188	0
K981199	MICROSCAN DRIED GRAM NEGATIVE MIC/COMBO PANELS , ESBL SCREEN	Dade Microscan, Inc.	1998-11-18	230	0
K972799	DRIED GRAM-POSITIVE MIC/COMBO PANELS	Dade Microscan, Inc.	1997-10-10	74	0
K972688	MICROSCAN DRIED GRAM POSITIVE MIC/COMBO PANELS LEVOFLOXACIN	Dade Microscan, Inc.	1997-09-08	63	0
K972180	DRIED GRAM-NEGATIVE MIC/COMBO PANELS	Dade Microscan, Inc.	1997-08-01	52	0
K971376	DRIED GRAM-NEGATIVE MIC/COMBO PANELS	Dade Microscan, Inc.	1997-05-30	46	0
K963641	STREPTOCOCCUS MIC PANEL	Dade Microscan, Inc.	1996-12-18	97	0
K961042	MICROSCAN RAPID GRAM-NEGATIVE INDENTIFICATION TYPE 3 PANEL	Dade Microscan, Inc.	1996-05-30	77	0
K955910	DRIED GRAM-NEGATIVE MIC/COMBO PANELS	Dade Microscan, Inc.	1996-02-23	56	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