CANCER ANTIGEN CONTROL
FDA 510(k) clearance K924061 · decided 1993-02-23
Clearance details
- K-number
- K924061
- Device name
- CANCER ANTIGEN CONTROL
- Applicant
- Polymedco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1992-08-12
- Decision date
- 1993-02-23
- Days to decision
- 195 days
- Clearance type
- Traditional
- Product code
- JJY
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Cortlandt Manor, NY, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| OC-Auto FOBT-CHEK Negative Controls is the negative hemoglobin control materials designed recall (Z-0538-2026) | POLYMEDCO, INC. / POLYMEDCO CANCER DIAGNOSTIC PRODUCTS, LLC | 2025-11-17 |