I-STAT 200 PORTABLE CLINICAL ANALYZER
FDA 510(k) clearance K940918 · decided 1994-05-10
Clearance details
- K-number
- K940918
- Device name
- I-STAT 200 PORTABLE CLINICAL ANALYZER
- Applicant
- I-Stat Corp.
- Decision
- Substantially Equivalent
- Date received
- 1994-02-25
- Decision date
- 1994-05-10
- Days to decision
- 74 days
- Clearance type
- Traditional
- Product code
- CHL
- Device class
- 2
- Regulation number
- 862.1120
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Princeton, NJ, US
- Third-party review
- No
- Expedited review
- No
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