FETAL CHECK
FDA 510(k) clearance K792546 · decided 1979-12-18
Clearance details
- K-number
- K792546
- Device name
- FETAL CHECK
- Applicant
- Alta Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1979-12-10
- Decision date
- 1979-12-18
- Days to decision
- 8 days
- Clearance type
- Traditional
- Product code
- KJR
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, 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 |
|---|---|---|
| PMK PRIMARY MONKEY KIDNEY-CELLS (K842833) | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-28 |
| HEP-2 CELLS (K842834) | Bartels Immunodiagnostic Supplies, Inc. | 1984-08-28 |
Recalls involving this device
No recalls on record reference this clearance.