510(k) K880294
- Device
- DART PHENYTOIN
- Applicant
- COULTER ELECTRONICS, INC.
- 510(k) number
- K880294
- Product code
- LFO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1988-05-27
- Date received
- 1988-01-25
- Regulation
- 862.3350
- Classification name
- Nephelometric Inhibition Immunoassay, Diphenylhydantoin
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- A RICHARDSON-JONES
- Address
- 745 W. 83rd St. Hialeah FL US 33014 33014
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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