ALKALINE PHOSPHATASE, LEUKOCYTE, KIT
FDA 510(k) clearance K896092 · decided 1989-11-09
Clearance details
- K-number
- K896092
- Device name
- ALKALINE PHOSPHATASE, LEUKOCYTE, KIT
- Applicant
- Sigma Chemical Co.
- Decision
- Substantially Equivalent
- Date received
- 1989-10-19
- Decision date
- 1989-11-09
- Days to decision
- 21 days
- Clearance type
- Traditional
- Product code
- GHD
- Device class
- 1
- Regulation number
- 864.7660
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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 |
|---|---|---|
| NITRO BLUE TETRAZOLIUM REDUCTION (K904022) | Sigma Chemical Co. | 1990-12-18 |
| NAPHTHOL AS-D CHLOR/A-NAPHTHYL ACET ESTERASE KIT (K903995) | Sigma Chemical Co. | 1990-12-13 |
| CHEMSTRIP L (K811189) | Biodynamics Corp. | 1981-07-27 |
Recalls involving this device
No recalls on record reference this clearance.