FRUCTOSAMINE, MODEL FR 106-01— 510(k) K991246
Substantially EquivalentA.P. Total Care, Inc.
FDA 510(k) clearance K991246 for FRUCTOSAMINE, MODEL FR 106-01, Substantially Equivalent on 1999-12-16. Applicant: A.P. Total Care, Inc.. Device class: 2.
Clearance details
- Applicant
- A.P. Total Care, Inc.
- Product code
- Code LCP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7470
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bridgeport, CT, US
Recent devices under product code LCP
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- K991665 — HDL CHOLESTEROL, PRODUCT NO'S 124-01, CH102-01
- K991866 — BILIRUBIN, TOTAL AND DIRECT, PRODUCT NO, 122-01, 122-02, 122-03, 122-04
Data sourced from openFDA. This site is unofficial and independent of the FDA.