CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ— 510(k) K853050
Substantially EquivalentSimmler, Inc.
FDA 510(k) clearance K853050 for CALCIUM REAGENT FOR ASTRA 8 AUTOM STAT/ROUT/ANALYZ, Substantially Equivalent on 1985-08-02. Applicant: Simmler, Inc.. Device class: 2.
Clearance details
- Applicant
- Simmler, Inc.
- Product code
- Code CIC
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Louis, MO, US
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