HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808— 510(k) K941764
Substantially EquivalentHi Chem, Inc.
FDA 510(k) clearance K941764 for HICHEM CALCIUM REAGENT FOR THE SYNCHRON CX3 PROD. NO. 88808, Substantially Equivalent on 1994-05-13. Applicant: Hi Chem, Inc.. Device class: 2.
Clearance details
- Applicant
- Hi Chem, Inc.
- Product code
- Code CJY
- Device class
- Class 2
- Regulation
- 21 CFR 862.1145
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brea, CA, US
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