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

Dade Behring, Inc. — Predicate Candidate Screening

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

56 daysmedian FDA review time

120 days90th percentile

343clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K093848	PT-MULTI-CALIBRATOR, MODEL OPAT07	Dade Behring, Inc.	2010-12-20	369	0
K081161	DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION	Dade Behring, Inc.	2008-07-28	95	0
K081249	DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSI	Dade Behring, Inc.	2008-07-21	80	0
K071603	DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRI	Dade Behring, Inc.	2008-06-25	379	0
K071597	DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K64	Dade Behring, Inc.	2008-06-04	358	0
K073604	DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION F	Dade Behring, Inc.	2008-03-13	83	7
K073561	DIMENSION VISTA SYSTEM IMMUNOGLOBULIN G FLEX REAGENT CARTRID	Dade Behring, Inc.	2008-02-26	69	0
K073072	DIMENSION AHDL FLEX REAGENT CARTRIDGE, MODEL: DF48B	Dade Behring, Inc.	2008-02-21	113	0
K073055	DIMENSION ENZYMATIC CREATININE FLEX REAGENT CARTRIDGE WITH M	Dade Behring, Inc.	2008-01-03	65	4
K072965	DIMENSION VISTA C1 IN; FLEX REAGENT CARTRIDGE, CAL, CON	Dade Behring, Inc.	2007-12-21	60	0
K072717	DIMENSION VISTA SYSTEM BILIRUBIN CALIBRATOR, MODEL KC210	Dade Behring, Inc.	2007-12-12	78	0
K071224	DIMENSION VISTA VITAMIN B12 AND FOLATE FLEX REAGENT CARTRIDG	Dade Behring, Inc.	2007-11-13	195	1
K072435	DIMENSION VISTA PROTEIN 3 CALIBRATOR, 3 CONTROL,1 CONTROL L,	Dade Behring, Inc.	2007-10-17	48	0
K072304	FIBRINOGEN CALIBRATOR KIT	Dade Behring, Inc.	2007-09-19	33	0
K071980	DIMENSION VISTA PROTEIN 1 CALIBRATOR, PROTEIN1 CONTROL L,M,H	Dade Behring, Inc.	2007-09-11	55	0
K071811	ETOH FLEX REAGENT CARTRIDGE (DF22)	Dade Behring, Inc.	2007-08-24	52	1
K071317	MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW	Dade Behring, Inc.	2007-08-20	102	0
K071316	MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS NEW	Dade Behring, Inc.	2007-08-20	102	0
K071834	STRATUS CS ACUTE CARE NT-PROBNP TESTPAK, MODEL CPBNPM	Dade Behring, Inc.	2007-08-17	45	2
K071247	N LATEX RF KIT	Dade Behring, Inc.	2007-08-08	96	0
K071767	DIMENSIONS PBNP FLEX REAGENT CARTRIDGE, MODEL RF423A	Dade Behring, Inc.	2007-08-04	36	0
K070346	DADE BEHRING LABPRO ALERT SOFTWARE SYSTEM	Dade Behring, Inc.	2007-07-18	162	0
K071268	MICROSCAN SYNERGIES PLUS GRAM POSITIVE MIC/COMBO PANELS WITH	Dade Behring, Inc.	2007-06-26	50	0
K070853	DIMENSION VISTA ETOH FLEX REAGENT CARTRIDGE, MODEL K5022	Dade Behring, Inc.	2007-06-13	77	0
K071076	SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS	Dade Behring, Inc.	2007-05-21	35	0
K070860	MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH	Dade Behring, Inc.	2007-05-11	44	0
K070552	DIMENSION VISTA FERRITIN FLEX REAGENT CARTRIDGE (FERR)	Dade Behring, Inc.	2007-04-30	62	1
K063356	STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK	Dade Behring, Inc.	2007-03-23	136	1
K063663	DIMENSION VISTA STFR FLEX REAGENT CARTRIDGE AND PROTEIN 1 CA	Dade Behring, Inc.	2007-03-21	103	0
K063756	DIMENSION VISTA CTNI FLEX REAGENT CARTRIDGE	Dade Behring, Inc.	2007-03-19	90	1
K063608	DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND P	Dade Behring, Inc.	2007-02-23	81	0
K063754	DIMENSION VISTA (TM) BHCG FLEX(R) REAGENT CARTRIDGE, AND BHC	Dade Behring, Inc.	2007-02-23	66	0
K063425	DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBR	Dade Behring, Inc.	2007-02-15	94	0
K063655	DIMENSION VISTA; CER FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIB	Dade Behring, Inc.	2007-02-15	69	0
K063564	MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH	Dade Behring, Inc.	2007-02-08	72	0
K063272	DIMENSION VISTA B2MIC FLEX REAGENT CARTRIDGE, PROTEIN 1 CALI	Dade Behring, Inc.	2007-01-26	88	0
K063322	DIMENSION VISTA TRF FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBR	Dade Behring, Inc.	2007-01-24	82	0
K063508	DIMENSION VISTA PROTEIN 1 CALIBRATOR AND CONTROL L, M, H; PR	Dade Behring, Inc.	2007-01-23	64	0
K063351	DIMENSION VISTA CYSC FLEX REAGENT CARTRIDGE, PROTEIN 3 CALIB	Dade Behring, Inc.	2007-01-22	77	0
K063610	DIMENSION VISTA A1AT FLEX REAGENT CARTRIDGE AND PROTEIN 1 CA	Dade Behring, Inc.	2007-01-11	38	0
K063206	DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIB	Dade Behring, Inc.	2006-12-28	66	2
K062924	STRATUS CS ACUTE CARE CARDIOPHASE HSCRP TESTPAK	Dade Behring, Inc.	2006-12-26	89	1
K063365	SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH GENTAMICI	Dade Behring, Inc.	2006-12-08	31	0
K063366	MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANEL WITH	Dade Behring, Inc.	2006-12-08	31	0
K063299	MICROSCAN MICROSTREP PLUS PANEL-CLARITHROMYCIN	Dade Behring, Inc.	2006-11-27	26	0
K062938	MICROSCAN SYNERGIES PLUS GRAM-POSITIVE MIC/COMBO PANELS WITH	Dade Behring, Inc.	2006-11-20	53	0
K063102	MICROSCAN MICROSTREP PLUS PANEL CEFACLOR (0.5 - 8 MCG/ML)	Dade Behring, Inc.	2006-11-09	30	0
K063099	MICROSCAN MICROSTREP PLUS PANEL CEFEPIME (O.015 - 8 MCG/ML)	Dade Behring, Inc.	2006-11-01	22	0
K063101	MICROSCAN MICROSTREP PLUS PANEL CEFOTAXIME (0.015 - 8 MCG/ML	Dade Behring, Inc.	2006-11-01	22	0
K063065	MICROSCAN MICROSTREP PLUS PANEL MEROPENEM (0.03-4MCG/ML)	Dade Behring, Inc.	2006-10-27	21	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