ABSOLUTE(TM)-HCG URINE PREGNANCY TEST
FDA 510(k) clearance K893953 · decided 1989-08-15
Clearance details
- K-number
- K893953
- Device name
- ABSOLUTE(TM)-HCG URINE PREGNANCY TEST
- Applicant
- Totem Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1989-06-01
- Decision date
- 1989-08-15
- Days to decision
- 75 days
- Clearance type
- Traditional
- Product code
- DHA
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Vancouver, B.C. V5z 4h5, CA
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.