CREATININE REAGENT SET
FDA 510(k) clearance K860418 · decided 1986-02-11
Clearance details
- K-number
- K860418
- Device name
- CREATININE REAGENT SET
- Applicant
- Sterling Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-02-04
- Decision date
- 1986-02-11
- Days to decision
- 7 days
- Clearance type
- Traditional
- Product code
- CGX
- Device class
- 2
- Regulation number
- 862.1225
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Sterling Heights, MI, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Creatinine/Endpoint [Modified Heinegard-Tiderstrom] for IN VITRO DIAGNOSTIC USE in the qua recall (Z-0931-2017) | Sterling Diagnostics, Inc. | 2016-12-29 |