510(k) K900702
- Device
- MODIFIED ACCUFLUOR CARBAMAZEPINE REAGENT & CALIBRA
- Applicant
- INNOTRON OF OREGON, INC.
- 510(k) number
- K900702
- Product code
- LGI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1990-04-12
- Date received
- 1990-02-12
- Regulation
- 862.3645
- Classification name
- Fluorescence Polarization Immunoassay, Carbamazepine
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CRAIG SMART
- Address
- 4432 Se16th.Ave. Portland OR US 97202 97202
FDA Registration Numbers#
- 3006198300
- 3003795116
- 9610126
- 9610529
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LGI #
Legacy Summary#
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FDA Review#
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