COULTER VISCOMETER II
FDA 510(k) clearance K883503 · decided 1988-09-19
Clearance details
- K-number
- K883503
- Device name
- COULTER VISCOMETER II
- Applicant
- Coulter Electronics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-08-17
- Decision date
- 1988-09-19
- Days to decision
- 33 days
- Clearance type
- Traditional
- Product code
- JJL
- Device class
- 1
- Regulation number
- 862.2920
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hialeah, FL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.