AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781
FDA 510(k) clearance K900250 · decided 1990-03-01
Clearance details
- K-number
- K900250
- Device name
- AMRESCO ALKALINE PHOSPHATASE REAGENTS 7780 & 7781
- Applicant
- American Research Products Co.
- Decision
- Substantially Equivalent
- Date received
- 1990-01-17
- Decision date
- 1990-03-01
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- CJE
- Device class
- 2
- Regulation number
- 862.1050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Solon, OH, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.