510(k) K893507
- Device
- INNOFLUOR CARBAMAZEPINE REAGENT SET
- Applicant
- INNOTRON OF OREGON, INC.
- 510(k) number
- K893507
- Product code
- KLT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-08-11
- Date received
- 1989-05-05
- Regulation
- 862.3645
- Classification name
- Enzyme Immunoassay, Carbamazepine
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- JANELLE BATLEY
- Address
- 4432 Se16th.Ave. Portland OR US 97202 97202
FDA Registration Numbers#
- 3012963943
- 2432235
- 3004493545
- 1319809
- 2517506
- 3002806944
- 3005333358
- 1181121
- 3002809144
- 2050010
- 1319681
- 3000308930
- 2050012
- 9610126
- 3006198300
- 3002642396
- 3010939897
- 2250051
- 3010825766
- 1036362
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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