CIBA CORNING/SHIMADZU MODEL 570 CHEM. ANALYZER
FDA 510(k) clearance K873749 · decided 1987-10-19
Clearance details
- K-number
- K873749
- Device name
- CIBA CORNING/SHIMADZU MODEL 570 CHEM. ANALYZER
- Applicant
- Ciba Corning Diagnostics Corp.
- Decision
- Substantially Equivalent
- Date received
- 1987-09-15
- Decision date
- 1987-10-19
- Days to decision
- 34 days
- Clearance type
- Traditional
- Product code
- JJE
- Device class
- 1
- Regulation number
- 862.2160
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- East Walpole, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.