ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
FDA 510(k) clearance K993317 · decided 1999-12-01
Clearance details
- K-number
- K993317
- Device name
- ACON HCG ONE STEP PREGNANCY TEST DEVICE (URINE)
- Applicant
- ACON Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-10-04
- Decision date
- 1999-12-01
- Days to decision
- 58 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 |
|---|---|---|
| Cardinal Health hCG Cassette Rapid Test, Part Number: B1077-22 (Mfg PN: 4582105026) The SP recall (Z-1344-2013) | Alere San Diego, Inc. | 2013-05-21 |