FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300
K Number: K001387
·
Decision Oct 5, 2000
Classifications
1
FEI Numbers
131
Registration Numbers
131
Same Product Code
400
Applicant Total
14
Review Days
156
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Basic Information
- Device Name
- I-STAT PORTABLE CLINICAL ANALYZER, MODEL 300
- K Number
- K001387
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1345
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- I-Stat Corp.
- Date Received
- May 2, 2000
- Decision Date
- October 5, 2000
- Product Code
- CGA
- 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 |
|---|---|---|---|
| CGA | Glucose Oxidase, Glucose | FDA class 2 | Clinical Chemistry |
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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 |
| 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 |
| K934642 | I-STAT IONIZED CALCIUM TEST | Dec 17, 1993 | Substantially Equivalent |
| K934641 | I-STAT CONTROL LEVELS 1,2,3 | Dec 9, 1993 | Substantially Equivalent |