I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE— 510(k) K112430
Substantially EquivalentAbbott Pont of Care, Inc.
FDA 510(k) clearance K112430 for I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE, Substantially Equivalent on 2011-12-20. Applicant: Abbott Pont of Care, Inc.. Device class: 1.
Clearance details
- Applicant
- Abbott Pont of Care, Inc.
- Product code
- Code KHP
- Device class
- Class 1
- Regulation
- 21 CFR 862.1450
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Princton, NJ, US
Recent devices under product code KHP
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