ACON ONE STEP PREGNANCY TEST STRIP (URINE)
FDA 510(k) clearance K993203 · decided 1999-12-01
Clearance details
- K-number
- K993203
- Device name
- ACON ONE STEP PREGNANCY TEST STRIP (URINE)
- Applicant
- ACON Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-09-24
- Decision date
- 1999-12-01
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- JHI
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| a. ABBOTT RAPID DX N AMERICA LLC Alere Rapid Test Kit Alere Fertility Test hCG Pregnancy T recall (Z-1606-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-08-26 |
| ICON DS hCG, an in-vitro diagnostic. Part number 44025. recall (Z-0706-03) | Beckman Coulter Inc | 2003-04-02 |