BETA-HCG ASSAY
FDA 510(k) clearance K873986 · decided 1988-02-02
Clearance details
- K-number
- K873986
- Device name
- BETA-HCG ASSAY
- Applicant
- Schiff & Co.
- Decision
- Substantially Equivalent
- Date received
- 1987-09-29
- Decision date
- 1988-02-02
- Days to decision
- 126 days
- Clearance type
- Traditional
- Product code
- DHA
- Device class
- 2
- Regulation number
- 862.1155
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- West Cadwell, NJ, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.