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
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- RICHARDSON-JONES
- Address
- 745 W. 83rd St. Hialeah FL US 33014 33014
FDA Registration Numbers#
- 3031232529
- 3022099814
- 3014579291
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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