TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116— 510(k) K932980
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K932980 for TOTAL T4 FPIA REAGENT SET/CALIBRATOR #T-1039,T-116, Substantially Equivalent on 1993-10-18. Applicant: Sigma Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- Code CDX
- Device class
- Class 2
- Regulation
- 21 CFR 862.1700
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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