SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV— 510(k) K850368
Substantially EquivalentSigma Chemical Co.
FDA 510(k) clearance K850368 for SIGMS B-HYDROXYBUTARATE PROCEDURE NO. 310-UV, Substantially Equivalent on 1985-08-30. Applicant: Sigma Chemical Co.. Device class: 1.
Clearance details
- Applicant
- Sigma Chemical Co.
- Product code
- Code JIN
- Device class
- Class 1
- Regulation
- 21 CFR 862.1435
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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