ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K
FDA 510(k) clearance K990957 · decided 1999-05-11
Clearance details
- K-number
- K990957
- Device name
- ASTORIA-PACIFIC SPOTCHECK G6PD KIT 50 HR, MODEL 80-3000-13K
- Applicant
- Astoria-Pacific, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-03-22
- Decision date
- 1999-05-11
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- JBL
- Device class
- 2
- Regulation number
- 864.7360
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Clackamas, OR, 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 |
|---|---|---|
| DEHYDROGENOSE, GLUCOSE PHOSPHATE (K790211) | Sigma Chemical Co. | 1979-03-15 |
Recalls involving this device
No recalls on record reference this clearance.