Bile Acids Reagent
FDA 510(k) K872296 · Sigma Diagnostics, Inc.
510(k) numberK872296
Submission
- Device name
- Bile Acids Reagent
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- June 16, 1987
- Decision date
- August 26, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K062503 | Catachem, Inc., Bile Acids Reagents And/Or Bile Acids Test KitKWW · Traditional | Catachem, Inc. | 01/19/2007SE |
| K051714 | Total Bile Acids Assay, Model DZ042AKWW · Traditional | Diazyme Laboratories | 12/07/2005SE |
| K970120 | Bile Acids Reagent SetKWW · Traditional | Teco Diagnostics | 03/24/1997SE |
| 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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| K003267 | Sigma Diagnostics Auto D-Dimer, Model CRS126-ADAP · Traditional | 03/15/2001SE |
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Questions and answers
When was Bile Acids Reagent cleared by the FDA?
Bile Acids Reagent (K872296) received a 510(k) decision of Substantially Equivalent on August 26, 1987, 71 days after the submission was received.
What is the product code of K872296?
The FDA product code is KWW – Radioimmunoassay, Cholyglycine, Bile Acids, a Class II (moderate risk) device regulated under 21 CFR 862.1177.