I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK
FDA 510(k) clearance K912387 · decided 1991-07-01
Clearance details
- K-number
- K912387
- Device name
- I-STAT MODEL 100 PORT CLIN ANALYZER & TEST PACK
- Applicant
- I-Stat Corp.
- Decision
- Substantially Equivalent
- Date received
- 1991-05-01
- Decision date
- 1991-07-01
- Days to decision
- 61 days
- Clearance type
- Traditional
- Product code
- JGS
- Device class
- 2
- Regulation number
- 862.1665
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Princeton, NJ, US
- Third-party review
- No
- Expedited review
- No
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