510(k) K964009
- Device
- IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS
- Applicant
- BECKMAN INSTRUMENTS, INC.
- 510(k) number
- K964009
- Product code
- DNO
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1997-02-11
- Date received
- 1996-10-07
- Regulation
- 862.3450
- Classification name
- Hemagglutination Inhibition, Gentamicin
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANNETTE HELLIE
- Address
- 2470 Faraday Carlsbad CA US 92008 92008
Source Documents#
Legacy Summary#
summary
FDA Review#
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