FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT
FDA 510(k) clearance K881015 · decided 1988-08-29
Clearance details
- K-number
- K881015
- Device name
- FIRSTDAY(TM) EARLY PREGNANCY TESTING KIT
- Applicant
- Pacific Biotech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-03-10
- Decision date
- 1988-08-29
- Days to decision
- 172 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
No recalls on record reference this clearance.