ASSERACHROM TOTAL PROTEIN S KIT— 510(k) K954040
Substantially EquivalentAmerican Bioproducts Co.
FDA 510(k) clearance K954040 for ASSERACHROM TOTAL PROTEIN S KIT, Substantially Equivalent on 1995-11-13. Applicant: American Bioproducts Co.. Device class: 2.
Clearance details
- Applicant
- American Bioproducts Co.
- Product code
- Code GGP
- Device class
- Class 2
- Regulation
- 21 CFR 864.7290
- Advisory panel
- Hematology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Parisppany, NJ, US
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