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

Catachem, Inc. — Predicate Candidate Screening

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

57 daysmedian FDA review time

106 days90th percentile

41clearances measured

K-number	Device	Applicant	Decided	Review days
K062503	CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST K	Catachem, Inc.	2007-01-19	147
K945408	340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER	Catachem, Inc.	1995-02-22	111
K932871	UIBC FOR DISCREET RANDOM ACCESS ANALYZER	Catachem, Inc.	1993-09-08	86
K903341	MAGNESIUM	Catachem, Inc.	1990-08-22	28
K902326	AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS	Catachem, Inc.	1990-07-31	68
K902877	TOTAL IRON FOR MANUAL/AUTOMATED	Catachem, Inc.	1990-07-27	25
K895748	BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS	Catachem, Inc.	1989-12-21	86
K895821	URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS	Catachem, Inc.	1989-12-05	67
K894715	CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS	Catachem, Inc.	1989-11-08	106
K894389	CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS	Catachem, Inc.	1989-10-12	87
K894476	CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION	Catachem, Inc.	1989-10-12	86
K894173	BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT	Catachem, Inc.	1989-09-05	82
K892668	TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS	Catachem, Inc.	1989-07-20	98
K893884	BACTON TM, BASIC TM, APO B REAGENT	Catachem, Inc.	1989-06-21	22
K893885	BACTON TM, BASIC TM, APO A-I REAGENT	Catachem, Inc.	1989-06-21	22
K892905	DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI.	Catachem, Inc.	1989-06-19	60
K891240	DIRECT BILIRUBIN FOR CONTINUOUS FLOW	Catachem, Inc.	1989-05-10	64
K891025	TOTAL BILIRUBIN FOR CONTINUOUS FLOW	Catachem, Inc.	1989-04-04	35
K884724	ASPARTATE AMINOTRANSFERASE (AST)	Catachem, Inc.	1989-03-08	118
K884936	ALANINE AMINOTRANSFERASE	Catachem, Inc.	1989-01-03	39
K883792	TOTAL IRON FOR CONTINUOUS FLOW INSTRUMENTS	Catachem, Inc.	1988-10-12	35
K880308	CALCIUM	Catachem, Inc.	1988-05-27	123
K881400	CREATININE FOR CONTINUOUS FLOW INSTRUMENTS	Catachem, Inc.	1988-04-28	24
K875222	TOTAL PROTEIN	Catachem, Inc.	1988-01-22	31
K874532	BLOOD UREA NITROGEN	Catachem, Inc.	1988-01-05	63
K874472	INORGANIC PHOSPHORUS	Catachem, Inc.	1987-12-22	50
K874163	ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS	Catachem, Inc.	1987-11-23	41
K873378	GAMMA GLUTAMYLTRANSFERASE	Catachem, Inc.	1987-09-08	15
K872886	CARBON DIOXIDE	Catachem, Inc.	1987-08-13	22
K872511	CHLORIDE FOR CONTINUOUS FLOW INSTRUMENTS	Catachem, Inc.	1987-07-21	27
K871543	ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU.	Catachem, Inc.	1987-06-22	63
K871677	CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS	Catachem, Inc.	1987-05-12	14
K870086	ALANINE AMINOTRANSFERASE (ALT)/(GPT)	Catachem, Inc.	1987-03-06	57
K870077	ASPARTATE AMINOTRANSFERASE (AST)/(GOT)	Catachem, Inc.	1987-03-06	57
K863287	URIC ACID (URICASE) METHOD-II	Catachem, Inc.	1986-09-29	35
K861635	TRIGLYCERIDES GPO-TRINDER	Catachem, Inc.	1986-06-27	59
K860713	LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM.	Catachem, Inc.	1986-04-24	57
K860690	TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS	Catachem, Inc.	1986-03-17	20
K853825	URIC ACID(URICASE) FOR CONTINUOUS FLOW INSTRUMENTS	Catachem, Inc.	1985-09-30	17
K853826	GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS	Catachem, Inc.	1985-09-30	17
K852863	CHOLESTEROL METHOD	Catachem, Inc.	1985-07-23	15

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