510(k) K961984
- Device
- PORPHOBILINOGEN (PBG)
- Applicant
- TRACE AMERICA, INC.
- 510(k) number
- K961984
- Product code
- JNF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1996-12-10
- Date received
- 1996-05-21
- Regulation
- 862.1590
- Classification name
- Ion-exchange Resin, Ehrlich's Reagent, Porphobilinogen
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- David Johnston
- Address
- 7260 NW 58th St. Miami FL US 33166 33166
FDA Registration Numbers#
- 1832216
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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