DYNAZYME II GPT 340— 510(k) K771152
Substantially EquivalentJ.T. Baker Chemical Co.
FDA 510(k) clearance K771152 for DYNAZYME II GPT 340, Substantially Equivalent on 1977-11-03. Applicant: J.T. Baker Chemical Co.. Device class: 1.
Clearance details
- Applicant
- J.T. Baker Chemical Co.
- 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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