Catachem, Inc.
Oxford, CT, US
CATACHEM, INC. appears in FDA device records in Oxford, CT. FDA records list 41 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 41 510(k) clearances for Catachem, Inc. between 1985 and 2007. The busiest year on record is 1989, with 14. The most recent is 2007, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1985 | 3 |
| 1986 | 4 |
| 1987 | 9 |
| 1988 | 5 |
| 1989 | 14 |
| 1990 | 3 |
| 1993 | 1 |
| 1995 | 1 |
| 2007 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K062503 | CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT | KWW | Substantially Equivalent | |
| K945408 | 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER | CHJ | Substantially Equivalent | |
| K932871 | UIBC FOR DISCREET RANDOM ACCESS ANALYZER | CFM | Substantially Equivalent | |
| K903341 | MAGNESIUM | JGJ | Substantially Equivalent | |
| K902326 | AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS | JFJ | Substantially Equivalent | |
| K902877 | TOTAL IRON FOR MANUAL/AUTOMATED | JIY | Substantially Equivalent | |
| K895748 | BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS | KHS | Substantially Equivalent | |
| K895821 | URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS | KNK | Substantially Equivalent | |
| K894715 | CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS | CGS | Substantially Equivalent | |
| K894476 | CALCIUM (ARSENAZO III) FOR MANUAL/AUTO APPLICATION | CJY | Substantially Equivalent | |
| K894389 | CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS | GGX | Substantially Equivalent | |
| K894173 | BUN-BLOOD UREA NITROGEN FOR MANUAL/AUTO APPLICAT | CDQ | Substantially Equivalent | |
| K892668 | TOTAL BILIRUBIN FOR MANUAL/AUTOMATED APPLICATIONS | CIG | Substantially Equivalent | |
| K893885 | BACTON TM, BASIC TM, APO A-I REAGENT | DEL | Substantially Equivalent | |
| K893884 | BACTON TM, BASIC TM, APO B REAGENT | MSJ | Substantially Equivalent | |
| K892905 | DIRECT BILIRUBIN FOR MANUAL OR AUTOMATED APPLI. | CIG | Substantially Equivalent | |
| K891240 | DIRECT BILIRUBIN FOR CONTINUOUS FLOW | CIG | Substantially Equivalent | |
| K891025 | TOTAL BILIRUBIN FOR CONTINUOUS FLOW | CIG | Substantially Equivalent | |
| K884724 | ASPARTATE AMINOTRANSFERASE (AST) | CIT | Substantially Equivalent | |
| K884936 | ALANINE AMINOTRANSFERASE | CKA | Substantially Equivalent | |
| K883792 | TOTAL IRON FOR CONTINUOUS FLOW INSTRUMENTS | JIY | Substantially Equivalent | |
| K880308 | CALCIUM | CIC | Substantially Equivalent | |
| K881400 | CREATININE FOR CONTINUOUS FLOW INSTRUMENTS | CGX | Substantially Equivalent | |
| K875222 | TOTAL PROTEIN | CEK | Substantially Equivalent | |
| K874532 | BLOOD UREA NITROGEN | CDW | Substantially Equivalent | |
| K874472 | INORGANIC PHOSPHORUS | CEO | Substantially Equivalent | |
| K874163 | ALBUMIN (BCG) FOR CONTINUOUS FLOW INSTRUMENTS | CIX | Substantially Equivalent | |
| K873378 | GAMMA GLUTAMYLTRANSFERASE | JQB | Substantially Equivalent | |
| K872886 | CARBON DIOXIDE | KMS | Substantially Equivalent | |
| K872511 | CHLORIDE FOR CONTINUOUS FLOW INSTRUMENTS | CHJ | Substantially Equivalent | |
| K871543 | ALKALINE PHOSPHATASE (AP) FOR CONT. FLOW INSTRU. | CJE | Substantially Equivalent | |
| K871677 | CREATINE KINASE FOR CONTINUOUS FLOW INSTRUMENTS | JHY | Substantially Equivalent | |
| K870086 | ALANINE AMINOTRANSFERASE (ALT)/(GPT) | CKA | Substantially Equivalent | |
| K870077 | ASPARTATE AMINOTRANSFERASE (AST)/(GOT) | CIT | Substantially Equivalent | |
| K863287 | URIC ACID (URICASE) METHOD-II | JHC | Substantially Equivalent | |
| K861635 | TRIGLYCERIDES GPO-TRINDER | CDT | Substantially Equivalent | |
| K860713 | LACTATE DEHYDROGENASE (LD) FOR CONT. FLOW INSTRUM. | CFJ | Substantially Equivalent | |
| K860690 | TRIGLYCERIDES FOR CONTINUOUS FLOW INSTRUMENTS | CDT | Substantially Equivalent | |
| K853826 | GLUCOSE HEXOKINASE FOR CONTINUOUS FLOW INSTRUMENTS | CFR | Substantially Equivalent | |
| K853825 | URIC ACID(URICASE) FOR CONTINUOUS FLOW INSTRUMENTS | KNK | Substantially Equivalent | |
| K852863 | CHOLESTEROL METHOD | CHH | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2434178 | 2434178 | CATACHEM, INC. | 353 Christian St Ste 2, Oxford, CT 06478 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- KNKAcid, Uric, Uricase (Colorimetric)
- JHCAcid, Uric, Uricase (Oxygen Rate)
- CGXAlkaline Picrate, Colorimetry, Creatinine
- MSJApolipoproteins
- CJYAzo Dye, Calcium
- CFMBathophenanthroline, Colorimetry, Iron (Non-Heme)
- CEKBiuret (Colorimetric), Total Protein
- CIXBromcresol Green Dye-Binding, Albumin
- JISCalibrator, Primary
- JFJCatalytic Methods, Amylase
- JHYColorimetric Method, Cpk Or Isoenzymes
- CICCresolphthalein Complexone, Calcium
- CDWDiacetyl-Monoxime, Urea Nitrogen
- CIGDiazo Colorimetry, Bilirubin
- CHHEnzymatic Esterase--Oxidase, Cholesterol
- KHSEnzymatic, Carbon-Dioxide
- CFRHexokinase, Glucose
- JQBKinetic Method, Gamma-Glutamyl Transpeptidase
- CDTLipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
- DELLipoprotein X, Antigen, Antiserum, Control
- CHJMercuric Thiocyanate, Colorimetry, Chloride
- CGSNad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- CFJNad Reduction/Nadh Oxidation, Lactate Dehydrogenase
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- CITNadh Oxidation/Nad Reduction, Ast/Sgot
- CJENitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes
- KMSPhenolphthalein Colorimetry, Carbon-Dioxide
- CEOPhosphomolybdate (Colorimetric), Inorganic Phosphorus
- JIYPhotometric Method, Iron (Non-Heme)
- JGJPhotometric Method, Magnesium
- GGXPipette, Sahli
- KWWRadioimmunoassay, Cholyglycine, Bile Acids
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- CDQUrease And Glutamic Dehydrogenase, Urea Nitrogen
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain