510(k) K832447
- Device
- STRATUS CARBAMAZEPINE FLUROMETRIC
- Applicant
- AMERICAN DADE
- 510(k) number
- K832447
- Product code
- KLT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-09-12
- Date received
- 1983-07-25
- 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#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3005333358
- 2050012
- 2432235
- 9610126
- 3010825766
- 2050010
- 1319809
- 1181121
- 3012963943
- 3000308930
- 3004493545
- 3002642396
- 3002806944
- 3006198300
- 3010939897
- 1319681
- 1036362
- 2517506
- 2250051
- 3002809144
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases