FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
I-STAT IONIZED CALCIUM TEST
K Number: K934642
·
Decision Dec 17, 1993
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
28
Applicant Total
14
Review Days
87
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 IONIZED CALCIUM TEST
- K Number
- K934642
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- I-Stat Corp.
- Date Received
- September 21, 1993
- Decision Date
- December 17, 1993
- Product Code
- JFP
- 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 |
|---|---|---|---|
| JFP | Electrode, Ion Specific, Calcium | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JFP), ordered by most recent decision date.
i-STAT CG8+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
i-STAT CHEM8+ cartridge with the i-STAT 1 System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Stat Profile Prime ES Comp Plus Analyzer System
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EasyLyte Na/K/Cl/Ca Analyzer
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AVL OPTI CRITICAL CARE ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AVL 9181 ELECTROLYTE ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by I-Stat Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K012478 | MODIFICATION TO: I-STAT PORTABLE CLINICAL ANALYZER | Aug 20, 2001 | Substantially Equivalent |
| K011478 | I-STAT SYSTEM | Jul 2, 2001 | Substantially Equivalent |
| K001387 | I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300 | Oct 5, 2000 | Substantially Equivalent |
| K001154 | I-STAT MODEL 200 PORTABLE CLINICAL ANALYZER | Apr 18, 2000 | Substantially Equivalent |
| K992571 | I-STAT SYSTEM | Feb 10, 2000 | Substantially Equivalent |
| K982071 | I-STAT LACTATE TEST | Jun 29, 1998 | Substantially Equivalent |
| K973292 | I-STAT SYSTEM | Oct 20, 1997 | Substantially Equivalent |
| K940918 | I-STAT 200 PORTABLE CLINICAL ANALYZER | May 10, 1994 | Substantially Equivalent |
| K936081 | I-STAT TESTS FOR ACID-BASE PARAMETERS | Feb 24, 1994 | Substantially Equivalent |
| K934641 | I-STAT CONTROL LEVELS 1,2,3 | Dec 9, 1993 | Substantially Equivalent |