IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS
FDA 510(k) clearance K964009 · decided 1997-02-11
Clearance details
- K-number
- K964009
- Device name
- IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS
- Applicant
- Beckman Instruments, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-07
- Decision date
- 1997-02-11
- Days to decision
- 127 days
- Clearance type
- Traditional
- Product code
- DNO
- Device class
- 2
- Regulation number
- 862.3450
- Medical specialty
- Clinical Toxicology
- Advisory committee
- Clinical Toxicology
- Location
- Carlsbad, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.