FLOW-PAC ALKALINE PHOSPHATE REAGENT SET
FDA 510(k) clearance K830535 · decided 1983-03-24
Clearance details
- K-number
- K830535
- Device name
- FLOW-PAC ALKALINE PHOSPHATE REAGENT SET
- Applicant
- Amresco, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-02-18
- Decision date
- 1983-03-24
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- CJF
- Device class
- 2
- Regulation number
- 862.1035
- 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.