AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS— 510(k) K902326
Substantially EquivalentCatachem, Inc.
FDA 510(k) clearance K902326 for AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS, Substantially Equivalent on 1990-07-31. Applicant: Catachem, Inc.. Device class: 2.
Clearance details
- Applicant
- Catachem, Inc.
- Product code
- Code JFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bridgeport, CT, US
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