ERYTHOCYTE CREATINE
FDA 510(k) clearance K852767 · decided 1986-11-13
Clearance details
- K-number
- K852767
- Device name
- ERYTHOCYTE CREATINE
- Applicant
- Panmed, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-28
- Decision date
- 1986-11-13
- Days to decision
- 503 days
- Clearance type
- Traditional
- Product code
- JLA
- Device class
- 1
- Regulation number
- 862.1210
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Three Oaks, MI, 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 |
|---|---|---|
| ASSERACHROM PROTEIN C KIT (K854016) | American Bioproducts Co. | 1986-01-03 |
Recalls involving this device
No recalls on record reference this clearance.