TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST
FDA 510(k) clearance K852751 · decided 1985-08-20
Clearance details
- K-number
- K852751
- Device name
- TOLVIDINE RED UNHEATED SERUM SYPHILLIS CARD TEST
- Applicant
- Preco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-28
- Decision date
- 1985-08-20
- Days to decision
- 53 days
- Clearance type
- Traditional
- Product code
- GMQ
- Device class
- 2
- Regulation number
- 866.3820
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Oakland, NJ, US
- Third-party review
- No
- Expedited review
- No
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| TRUST (K954994) | Guardian Scientific, Corp. | 1996-10-18 |
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Recalls involving this device
No recalls on record reference this clearance.