ALKALINE PHOSPHATASE REAGENT SET
FDA 510(k) clearance K812837 · decided 1982-01-29
Clearance details
- K-number
- K812837
- Device name
- ALKALINE PHOSPHATASE REAGENT SET
- Applicant
- Anco Medical Reagents & Assoc.
- Decision
- Substantially Equivalent
- Date received
- 1981-10-09
- Decision date
- 1982-01-29
- Days to decision
- 112 days
- Clearance type
- Traditional
- Product code
- CJL
- Device class
- 2
- Regulation number
- 862.1050
- 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.