510(k) K963673
- Device
- IMMAGE IMMUNOCHEMISTRY SYSTEM TDM (CAR,PHE,PHY, & THE) REAGENTS
- Applicant
- BECKMAN INSTRUMENTS, INC.
- 510(k) number
- K963673
- Product code
- KLT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-02-04
- Date received
- 1996-09-13
- Regulation
- 862.3645
- Classification name
- Enzyme Immunoassay, Carbamazepine
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANNETTE HELLIE
- Address
- 200 S. Kraemer Blvd., W-337 Box 8000 Brea CA US 92622 92622
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#
Legacy Summary#
summary
FDA Review#
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