Catachem, Inc., Bile Acids Reagents And/Or Bile Acids Test Kit
FDA 510(k) K062503 · Catachem, Inc.
510(k) numberK062503
Submission
- Device name
- Catachem, Inc., Bile Acids Reagents And/Or Bile Acids Test Kit
- Applicant
- Catachem, Inc.
Bridgeport, CT, US - Received
- August 25, 2006
- Decision date
- January 19, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KWW – Radioimmunoassay, Cholyglycine, Bile Acids
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1177
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KWW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K051714 | Total Bile Acids Assay, Model DZ042AKWW · Traditional | Diazyme Laboratories | 12/07/2005SE |
| K970120 | Bile Acids Reagent SetKWW · Traditional | Teco Diagnostics | 03/24/1997SE |
| K872296 | Bile Acids ReagentKWW · Traditional | Sigma Diagnostics, Inc. | 08/26/1987SE |
| K803296 | Endab Cholylglycine Enzyme Immuno. KitKWW · Traditional | Immunotech Corp. | 01/16/1981SE |
| K781337 | Conjugated Bile Acids Ria KitKWW · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 08/11/1978SE |
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| K945408 | 340-CHLORIDE for Discrete Random Access AnalyzerCHJ · Traditional | 02/22/1995SE |
| K932871 | Uibc for Discreet Random Access AnalyzerCFM · Traditional | 09/08/1993SE |
| K903341 | MagnesiumJGJ · Traditional | 08/22/1990SE |
| K902326 | Amylase for Manual/Automated ApplicationsJFJ · Traditional | 07/31/1990SE |
| K902877 | Total Iron for Manual/AutomatedJIY · Traditional | 07/27/1990SE |
| K895748 | Bicarbonate for Manual/Automated ApplicationsKHS · Traditional | 12/21/1989SE |
| K895821 | Uric Acid for Manual/Automated ApplicationsKNK · Traditional | 12/05/1989SE |
| K894715 | Creatine Kinase for Manual/Automated ApplicationsCGS · Traditional | 11/08/1989SE |
| K894476 | Calcium (Arsenazo III) for Manual/Auto ApplicationCJY · Traditional | 10/12/1989SE |
| K894389 | Creatinine for Manual or Automated ApplicationsGGX · Traditional | 10/12/1989SE |
Questions and answers
When was Catachem, Inc., Bile Acids Reagents And/Or Bile Acids Test Kit cleared by the FDA?
Catachem, Inc., Bile Acids Reagents And/Or Bile Acids Test Kit (K062503) received a 510(k) decision of Substantially Equivalent on January 19, 2007, 147 days after the submission was received.
What is the product code of K062503?
The FDA product code is KWW – Radioimmunoassay, Cholyglycine, Bile Acids, a Class II (moderate risk) device regulated under 21 CFR 862.1177.