DATA-ZYME LAT(GPT) PROCEDURE— 510(k) K801857
Substantially EquivalentData Medical Associates, Inc.
FDA 510(k) clearance K801857 for DATA-ZYME LAT(GPT) PROCEDURE, Substantially Equivalent on 1980-09-16. Applicant: Data Medical Associates, Inc.. Device class: 1.
Clearance details
- Applicant
- Data Medical Associates, Inc.
- Product code
- Code CKA
- Device class
- Class 1
- Regulation
- 21 CFR 862.1030
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mchenry, IL, US
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