PS-UNIT CASSETTE/SERUM HCG
FDA 510(k) clearance K963133 · decided 1996-11-18
Clearance details
- K-number
- K963133
- Device name
- PS-UNIT CASSETTE/SERUM HCG
- Applicant
- International Newtech Development, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-08-12
- Decision date
- 1996-11-18
- Days to decision
- 98 days
- Clearance type
- Traditional
- Product code
- JHI
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Richmond, B.C., CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| DiagnosUS hCG Pregnancy Serum/Urine Test Cassette Format REF 100-27 recall (Z-0065-2024) | Universal Meditech Inc. | 2023-10-23 |