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

Coulter Electronics, Inc. — Predicate Candidate Screening

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

53 daysmedian FDA review time

96 days90th percentile

101clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K923951	CD8 CYTOSPHERES KIT	Coulter Electronics, Inc.	1994-04-25	627	0
K930119	COULTER RETIC-C CELL CONTROL	Coulter Electronics, Inc.	1993-04-05	83	0
K921279	CD4 CYTOSPHERES KIT	Coulter Electronics, Inc.	1992-12-29	287	0
K923530	COULTER MULTI-Q-PREP	Coulter Electronics, Inc.	1992-10-14	90	0
K922181	COULTER MH009	Coulter Electronics, Inc.	1992-08-17	101	0
K922704	COULTER MAXM W/ AUTOLOADER	Coulter Electronics, Inc.	1992-07-27	52	1
K921567	COULTER MH017	Coulter Electronics, Inc.	1992-07-06	95	0
K912133	PX COULTER(R) CELL CONTROL	Coulter Electronics, Inc.	1991-07-17	64	0
K911385	COULTER(R) MH010	Coulter Electronics, Inc.	1991-06-17	81	1
K905771	COULTER DART AST (GOT) REAGENT	Coulter Electronics, Inc.	1991-02-26	61	0
K905767	COULTER DART ALT (GPT) REAGENT	Coulter Electronics, Inc.	1991-01-25	29	0
K905622	COULTER DIRECT BILLRUBIN REAGENT	Coulter Electronics, Inc.	1990-12-26	12	0
K904866	COULTER CK-MB ISOENZYME REAGENT	Coulter Electronics, Inc.	1990-12-13	45	0
K897162	COULTER CHOLESTEROL REAGENT	Coulter Electronics, Inc.	1990-03-29	91	0
K897160	COULTER GLUCOSE REAGENT	Coulter Electronics, Inc.	1990-03-09	71	0
K897159	COULTER TRIGLYCERIDES GPO REAGENT	Coulter Electronics, Inc.	1990-03-09	71	0
K897163	COULTER ALT (GPT) REAGENT	Coulter Electronics, Inc.	1990-03-09	71	0
K897164	COULTER LD (LDH-L) REAGENT	Coulter Electronics, Inc.	1990-03-09	71	0
K897161	COULTER URIC ACID REAGENT	Coulter Electronics, Inc.	1990-03-01	63	0
K897165	COULTER AST (GOT) REAGENT	Coulter Electronics, Inc.	1990-02-23	57	0
K897166	COULTER TOTAL PROTEIN REAGENT	Coulter Electronics, Inc.	1990-02-23	57	0
K894836	DART UREA NITROGEN	Coulter Electronics, Inc.	1989-10-30	91	0
K885332	COULTER FLOW RETICULOCYTE REAGENT	Coulter Electronics, Inc.	1989-02-22	56	0
K885028	COULTER 5P CONTROL	Coulter Electronics, Inc.	1989-02-16	73	0
K885093	COULTER STKS	Coulter Electronics, Inc.	1988-12-28	19	0
K883503	COULTER VISCOMETER II	Coulter Electronics, Inc.	1988-09-19	33	0
K883055	DART CARBON DIOXIDE	Coulter Electronics, Inc.	1988-08-30	42	0
K880294	DART PHENYTOIN	Coulter Electronics, Inc.	1988-05-27	123	0
K880507	COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTER	Coulter Electronics, Inc.	1988-04-04	55	0
K875047	COULTER CLONE T11 MONOCLONAL ANTIBODY	Coulter Electronics, Inc.	1988-03-09	92	0
K874838	COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT.	Coulter Electronics, Inc.	1988-02-19	87	0
K874188	COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STA	Coulter Electronics, Inc.	1988-01-19	97	0
K874185	DART (R) ELECTROLYTE REAGENT SYSTEM	Coulter Electronics, Inc.	1987-11-04	21	0
K872041	COULTER DART CK-MB ISOENZYME REAGENT SYSTEM	Coulter Electronics, Inc.	1987-09-16	112	0
K871837	COULTER COUNTER MODEL S-PLUS STKR	Coulter Electronics, Inc.	1987-07-02	51	0
K862122	S-CAL HEMATOLOGY CALIBRATOR	Coulter Electronics, Inc.	1987-05-20	351	0
K870736	DART THEOPHYLLINE REAGENT SYSTEM	Coulter Electronics, Inc.	1987-04-14	48	0
K864802	DART DIGOXIN ASSAY	Coulter Electronics, Inc.	1987-02-12	65	0
K864611	IMMUNO-SURE	Coulter Electronics, Inc.	1987-02-04	72	0
K864612	DART PHENOBARBITAL ASSAY SYSTEM	Coulter Electronics, Inc.	1987-01-13	50	0
K863085	COULTER COUNTER MODEL T-540	Coulter Electronics, Inc.	1986-09-04	23	0
K863084	COULTER COUNTER MODEL T-890	Coulter Electronics, Inc.	1986-09-04	23	0
K861780	COULTER COUNTER MODEL S PLUS JUNIOR	Coulter Electronics, Inc.	1986-08-06	90	0
K862370	DART AMYLASE-D.S. REAGENT SYSTEM	Coulter Electronics, Inc.	1986-08-01	38	0
K854708	DART CK-MB REAGENT SYSTEM	Coulter Electronics, Inc.	1985-12-30	38	0
K854305	DART IRON & IRON BINDING CAPACITY REAGENT	Coulter Electronics, Inc.	1985-11-12	18	0
K854114	COULTER COUNTER MODEL T-660	Coulter Electronics, Inc.	1985-11-05	28	0
K853429	COULTER COUNTER MODEL M5	Coulter Electronics, Inc.	1985-10-10	56	0
K851943	COULTER VOLUME ADAPTER	Coulter Electronics, Inc.	1985-08-30	119	0
K851736	COULTER CHANNELYZER 256	Coulter Electronics, Inc.	1985-07-30	96	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