SYPHILIS BIO-ENZABEAD KIT
FDA 510(k) clearance K820934 · decided 1982-06-10
Clearance details
- K-number
- K820934
- Device name
- SYPHILIS BIO-ENZABEAD KIT
- Applicant
- Biometics Laboratory Products
- Decision
- Substantially Equivalent
- Date received
- 1982-04-02
- Decision date
- 1982-06-10
- Days to decision
- 69 days
- Clearance type
- Traditional
- Product code
- LIP
- Device class
- 2
- Regulation number
- 866.3830
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.