I-STAT(TM) LEVELS 1,2,3 CONTROLS— 510(k) K921477
Substantially EquivalentI-Stat Corp.
FDA 510(k) clearance K921477 for I-STAT(TM) LEVELS 1,2,3 CONTROLS, Substantially Equivalent on 1992-11-02. Applicant: I-Stat Corp.. Device class: 1.
Clearance details
- Applicant
- I-Stat Corp.
- Product code
- Code JJY
- Device class
- Class 1
- Regulation
- 21 CFR 862.1660
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ontario K2l 1t9, Canada, CA
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