SICKLE CELL SOLUBILITY TEST KIT
FDA 510(k) clearance K895745 · decided 1989-11-29
Clearance details
- K-number
- K895745
- Device name
- SICKLE CELL SOLUBILITY TEST KIT
- Applicant
- Simmler, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-09-26
- Decision date
- 1989-11-29
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- JBB
- Device class
- 2
- Regulation number
- 864.7825
- 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 |
|---|---|---|
| SICKLE CELL TEST KIT (K932872) | Histo-Med, Inc. | 1993-08-16 |
Recalls involving this device
No recalls on record reference this clearance.