INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568)— 510(k) K001569
Substantially EquivalentSigma Diagnostics, Inc.
FDA 510(k) clearance K001569 for INFINITY AMYLASE REAGENT (PROCEDURE NO. 580/568), Substantially Equivalent on 2000-06-26. 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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Data sourced from openFDA. This site is unofficial and independent of the FDA.