ACON +/- MIDSTREAM PREGNANCY TEST
FDA 510(k) clearance K050546 · decided 2005-05-20
Clearance details
- K-number
- K050546
- Device name
- ACON +/- MIDSTREAM PREGNANCY TEST
- Applicant
- ACON Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-03-02
- Decision date
- 2005-05-20
- Days to decision
- 79 days
- Clearance type
- Special
- Product code
- LCX
- 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
No recalls on record reference this clearance.