ALT REAGENT (PROCEDURE NUMBER 159)— 510(k) K893560
Substantially EquivalentSigma Chemical Co.
FDA 510(k) clearance K893560 for ALT REAGENT (PROCEDURE NUMBER 159), Substantially Equivalent on 1989-07-20. Applicant: Sigma Chemical Co.. Device class: 1.
Clearance details
- Applicant
- Sigma 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
- St. Louis, MO, US
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