A-FACT, ABNORMAL FACTOR ASSAY CONTROL— 510(k) K945855
Substantially EquivalentGeorge King Bio-Medical, Inc.
FDA 510(k) clearance K945855 for A-FACT, ABNORMAL FACTOR ASSAY CONTROL, Substantially Equivalent on 1995-10-24. Applicant: George King Bio-Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- George King Bio-Medical, Inc.
- Product code
- Code GGN
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Overland Park, KS, US
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