8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO
FDA 510(k) clearance K792196 · decided 1979-11-13
Clearance details
- K-number
- K792196
- Device name
- 8 SUBJECT PHOTOVOLT ELECTROLYTE SERUM CO
- Applicant
- Photovolt Corp.
- Decision
- Substantially Equivalent
- Date received
- 1979-11-01
- Decision date
- 1979-11-13
- Days to decision
- 12 days
- Clearance type
- Traditional
- Product code
- JJR
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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.