AT-III CONTROL PLASMA KIT— 510(k) K955040
Substantially EquivalentAmerican Bioproducts Co.
FDA 510(k) clearance K955040 for AT-III CONTROL PLASMA KIT, Substantially Equivalent on 1996-01-31. Applicant: American Bioproducts Co.. Device class: 2.
Clearance details
- Applicant
- American Bioproducts Co.
- Product code
- Code GGC
- Device class
- Class 2
- Regulation
- 21 CFR 864.5425
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Parisppany, NJ, US
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