ION 2 REAGENT KI— 510(k) K851350
Substantially EquivalentHi Chem, Inc.
FDA 510(k) clearance K851350 for ION 2 REAGENT KI, Substantially Equivalent on 1985-04-29. Applicant: Hi Chem, Inc.. Device class: 2.
Clearance details
- Applicant
- Hi Chem, Inc.
- Product code
- Code CEM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1600
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
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