AMYLASE REAGENT (PROCEDURE 577)— 510(k) K913858
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K913858 for AMYLASE REAGENT (PROCEDURE 577), Substantially Equivalent on 1991-09-11. Applicant: Sigma Diagnostics, Inc.. Device class: 2.
Clearance details
- Applicant
- Sigma Diagnostics, Inc.
- Product code
- Code JFJ
- Device class
- Class 2
- Regulation
- 21 CFR 862.1070
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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