Company ยท US
Catachem, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2007. Name variants (Inc, Corp, punctuation) are merged.
41510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | 4 |
| CDT | Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides | 2 |
| CHJ | Mercuric Thiocyanate, Colorimetry, Chloride | 2 |
| CIT | Nadh Oxidation/Nad Reduction, Ast/Sgot | 2 |
| CKA | Nadh Oxidation/Nad Reduction, Alt/Sgpt | 2 |
| JIY | Photometric Method, Iron (Non-Heme) | 2 |
| KNK | Acid, Uric, Uricase (Colorimetric) | 2 |
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | 1 |
| CDW | Diacetyl-Monoxime, Urea Nitrogen | 1 |
| CEK | Biuret (Colorimetric), Total Protein | 1 |
| CEO | Phosphomolybdate (Colorimetric), Inorganic Phosphorus | 1 |
| CFJ | Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase | 1 |
| CFM | Bathophenanthroline, Colorimetry, Iron (Non-Heme) | 1 |
| CFR | Hexokinase, Glucose | 1 |
| CGS | Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes | 1 |
| CGX | Alkaline Picrate, Colorimetry, Creatinine | 1 |
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | 1 |
| CIC | Cresolphthalein Complexone, Calcium | 1 |
| CIX | Bromcresol Green Dye-Binding, Albumin | 1 |
| CJE | Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 19, 2007 | K062503 | CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT Catachem, Inc. | KWW |
| Feb 22, 1995 | K945408 | 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER Catachem, Inc. | CHJ |
| Sep 8, 1993 | K932871 | UIBC FOR DISCREET RANDOM ACCESS ANALYZER Catachem, Inc. | CFM |
| Aug 22, 1990 | K903341 | MAGNESIUM Catachem, Inc. | JGJ |
| Jul 31, 1990 | K902326 | AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS Catachem, Inc. | JFJ |
| Jul 27, 1990 | K902877 | TOTAL IRON FOR MANUAL/AUTOMATED Catachem, Inc. | JIY |
| Dec 21, 1989 | K895748 | BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS Catachem, Inc. | KHS |
| Dec 5, 1989 | K895821 | URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS Catachem, Inc. | KNK |
| Nov 8, 1989 | K894715 | CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS Catachem, Inc. | CGS |
| Oct 12, 1989 | K894476 | CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION Catachem, Inc. | CJY |
| Oct 12, 1989 | K894389 | CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS Catachem, Inc. | GGX |
| Sep 5, 1989 | K894173 | BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT Catachem, Inc. | CDQ |
| Jul 20, 1989 | K892668 | TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS Catachem, Inc. | CIG |
| Jun 21, 1989 | K893885 | BACTON TM, BASIC TM, APO A-I REAGENT Catachem, Inc. | DEL |
| Jun 21, 1989 | K893884 | BACTON TM, BASIC TM, APO B REAGENT Catachem, Inc. | MSJ |
| Jun 19, 1989 | K892905 | DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI. Catachem, Inc. | CIG |
| May 10, 1989 | K891240 | DIRECT BILIRUBIN FOR CONTINUOUS FLOW Catachem, Inc. | CIG |
| Apr 4, 1989 | K891025 | TOTAL BILIRUBIN FOR CONTINUOUS FLOW Catachem, Inc. | CIG |
| Mar 8, 1989 | K884724 | ASPARTATE AMINOTRANSFERASE (AST) Catachem, Inc. | CIT |
| Jan 3, 1989 | K884936 | ALANINE AMINOTRANSFERASE Catachem, Inc. | CKA |
| Oct 12, 1988 | K883792 | TOTAL IRON FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. | JIY |
| May 27, 1988 | K880308 | CALCIUM Catachem, Inc. | CIC |
| Apr 28, 1988 | K881400 | CREATININE FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. | CGX |
| Jan 22, 1988 | K875222 | TOTAL PROTEIN Catachem, Inc. | CEK |
| Jan 5, 1988 | K874532 | BLOOD UREA NITROGEN Catachem, Inc. | CDW |
| Dec 22, 1987 | K874472 | INORGANIC PHOSPHORUS Catachem, Inc. | CEO |
| Nov 23, 1987 | K874163 | ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. | CIX |
| Sep 8, 1987 | K873378 | GAMMA GLUTAMYLTRANSFERASE Catachem, Inc. | JQB |
| Aug 13, 1987 | K872886 | CARBON DIOXIDE Catachem, Inc. | KMS |
| Jul 21, 1987 | K872511 | CHLORIDE FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. | CHJ |
| Jun 22, 1987 | K871543 | ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU. Catachem, Inc. | CJE |
| May 12, 1987 | K871677 | CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. | JHY |
| Mar 6, 1987 | K870086 | ALANINE AMINOTRANSFERASE (ALT)/(GPT) Catachem, Inc. | CKA |
| Mar 6, 1987 | K870077 | ASPARTATE AMINOTRANSFERASE (AST)/(GOT) Catachem, Inc. | CIT |
| Sep 29, 1986 | K863287 | URIC ACID (URICASE) METHOD-II Catachem, Inc. | JHC |
| Jun 27, 1986 | K861635 | TRIGLYCERIDES GPO-TRINDER Catachem, Inc. | CDT |
| Apr 24, 1986 | K860713 | LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM. Catachem, Inc. | CFJ |
| Mar 17, 1986 | K860690 | TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. | CDT |
| Sep 30, 1985 | K853826 | GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. | CFR |
| Sep 30, 1985 | K853825 | URIC ACID(URICASE) FOR CONTINUOUS FLOW INSTRUMENTS Catachem, Inc. | KNK |
| Jul 23, 1985 | K852863 | CHOLESTEROL METHOD Catachem, Inc. | CHH |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||