FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
K Number: K112430
·
Decision Dec 20, 2011
Classifications
1
FEI Numbers
48
Registration Numbers
48
Same Product Code
26
Applicant Total
1
Review Days
118
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
- K Number
- K112430
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1450
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Pont of Care, Inc.
- Date Received
- August 24, 2011
- Decision Date
- December 20, 2011
- Product Code
- KHP
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KHP | Acid, Lactic, Enzymatic Method | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KHP), ordered by most recent decision date.
PICCOLO LACTATE TEST SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
RAPIDPOINT 500 BLOOD GAS ANALYER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM
FDA 510(k)
FDA Class 1
·Clinical Chemistry
NOVA STATSTRIP LACTATE HOSPITAL METER, NOVA STATSTRIP LACTATE TEST STRIPS
FDA 510(k)
FDA Class 1
·Clinical Chemistry
EPOC BGEM, EPOC READER, EPOC HOST, EPOC CARE-FILL CAPILLARY TUBE
FDA 510(k)
FDA Class 1
·Clinical Chemistry
IRMA SL BLOOD ANALYSIS SYSTEM LACTATE CARTRIDGE
FDA 510(k)
FDA Class 1
·Clinical Chemistry