LIQUI-SERA SERUM ALCOHOL CONTROLS
FDA 510(k) clearance K881430 · decided 1988-07-08
Clearance details
- K-number
- K881430
- Device name
- LIQUI-SERA SERUM ALCOHOL CONTROLS
- Applicant
- Biodiagnostic Intl
- Decision
- Substantially Equivalent
- Date received
- 1988-04-05
- Decision date
- 1988-07-08
- Days to decision
- 94 days
- Clearance type
- Traditional
- Product code
- JJX
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- La Habra, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.