SGOT/AST REAGENT SYSTEM
FDA 510(k) clearance K780443 · decided 1978-04-24
Clearance details
- K-number
- K780443
- Device name
- SGOT/AST REAGENT SYSTEM
- Applicant
- American Monitor Corp.
- Decision
- Substantially Equivalent
- Date received
- 1978-03-20
- Decision date
- 1978-04-24
- Days to decision
- 35 days
- Clearance type
- Traditional
- Product code
- CIT
- Device class
- 2
- Regulation number
- 862.1100
- 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.