IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER
FDA 510(k) clearance K970227 · decided 1997-04-08
Clearance details
- K-number
- K970227
- Device name
- IMMULITE 2000 AUTOMATED IMMUNOASSAY ANALYZER
- Applicant
- Dpc Cirrus
- Decision
- Substantially Equivalent
- Date received
- 1997-01-17
- Decision date
- 1997-04-08
- Days to decision
- 81 days
- Clearance type
- Traditional
- Product code
- JJE
- Device class
- 1
- Regulation number
- 862.2160
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Randolph, NJ, US
- Third-party review
- No
- Expedited review
- No
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