LIPASE DETERMINATION
FDA 510(k) clearance K800550 · decided 1980-04-02
Clearance details
- K-number
- K800550
- Device name
- LIPASE DETERMINATION
- Applicant
- The Dow Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1980-03-10
- Decision date
- 1980-04-02
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- CFG
- Device class
- 1
- Regulation number
- 862.1465
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, 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 |
|---|---|---|
| SERUM LIPASE REAGENT SET (TURBIDIMETRIC) (K860554) | Sterling Diagnostics, Inc. | 1986-03-14 |
Recalls involving this device
No recalls on record reference this clearance.