510(k) K883503
- Device
- COULTER VISCOMETER II
- Applicant
- COULTER ELECTRONICS, INC.
- 510(k) number
- K883503
- Product code
- JJL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-09-19
- Date received
- 1988-08-17
- Regulation
- 862.2920
- Classification name
- Plasma Viscometer For Clinical Use
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Clearance type
- Traditional
- Third party reviewed
- No
Legacy Summary#
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FDA Review#
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