PREGNANCY-SKREEN
FDA 510(k) clearance K050328 · decided 2005-03-29
Clearance details
- K-number
- K050328
- Device name
- PREGNANCY-SKREEN
- Applicant
- Biochemical Diagnostic, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-02-09
- Decision date
- 2005-03-29
- Days to decision
- 48 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Edgewood, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Abbott Rapid Dx N America LLC Reproductive Endocrinology Control Set McKesson Consult" Pre recall (Z-1312-2024) | Mckesson Medical-Surgical Inc. Corporate Office | 2024-03-19 |
| CONSULT(TM) diagnostics hCG CONTROLS Kit, Part/Reorder Number 5011, IVD Product Usage - CO recall (Z-0328-2016) | Biochemical Diagnostics Inc | 2015-11-23 |