P.A.P. TEST KIT, RIA-ZYME— 510(k) K790040
Substantially EquivalentMallinckrodt Critical Care
FDA 510(k) clearance K790040 for P.A.P. TEST KIT, RIA-ZYME, Substantially Equivalent on 1979-04-17. Applicant: Mallinckrodt Critical Care. Device class: 2.
Clearance details
- Applicant
- Mallinckrodt Critical Care
- Product code
- Product code JFH
- Device class
- Class 2
- Regulation
- 21 CFR 862.1020
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code JFH
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