CPK REAGENT SET— 510(k) K780070
Substantially EquivalentMedical Analysis Systems, Inc.
FDA 510(k) clearance K780070 for CPK REAGENT SET, Substantially Equivalent on 1978-02-13. Applicant: Medical Analysis Systems, Inc.. Device class: 2.
Clearance details
- Applicant
- Medical Analysis Systems, Inc.
- Product code
- Code CGS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1215
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
Recent devices under product code CGS
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