TRIGLYCERIDE (UV) REAGENT
FDA 510(k) clearance K872912 · decided 1987-08-17
Clearance details
- K-number
- K872912
- Device name
- TRIGLYCERIDE (UV) REAGENT
- Applicant
- Sigma Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1987-07-24
- Decision date
- 1987-08-17
- Days to decision
- 24 days
- Clearance type
- Traditional
- Product code
- JGW
- Device class
- 1
- Regulation number
- 862.1705
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- St. Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| TDX REA TRIGLYCERIDES (K852556) | Abbott Laboratories | 1985-07-22 |
| PRECIMAT GLYCEROL (K780439) | Boehringer Mannheim Corp. | 1978-04-18 |
Recalls involving this device
No recalls on record reference this clearance.