510(k) K894519
- Device
- FPR CARBAMAZEPINE KIT
- Applicant
- COLONY LABORATORIES, INC.
- 510(k) number
- K894519
- Product code
- KLT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-08-28
- Date received
- 1989-07-20
- Regulation
- 862.3645
- Classification name
- Enzyme Immunoassay, Carbamazepine
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- DALE B HINSON
- Address
- 1220 Nineteenth St., NW Fourth Floor Washington DC US 20036 20036
FDA Registration Numbers#
- 2432235
- 3012963943
- 1319681
- 2050010
- 3002642396
- 3010939897
- 2250051
- 3002809144
- 1181121
- 3004493545
- 9610126
- 1036362
- 3010825766
- 2517506
- 3002806944
- 3000308930
- 3005333358
- 2050012
- 1319809
- 3006198300
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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