The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Immage Immunochemistry System Gentamicin(gen)/tobramycin(tob) Reagent / Beckman Drug Claibrator 3 Plus.
| Device ID | K964009 |
| 510k Number | K964009 |
| Device Name: | IMMAGE IMMUNOCHEMISTRY SYSTEM GENTAMICIN(GEN)/TOBRAMYCIN(TOB) REAGENT / BECKMAN DRUG CLAIBRATOR 3 PLUS |
| Classification | Hemagglutination Inhibition, Gentamicin |
| Applicant | BECKMAN INSTRUMENTS, INC. 2470 FARADAY Carlsbad, CA 92008 -7224 |
| Contact | Annette Hellie |
| Correspondent | Annette Hellie BECKMAN INSTRUMENTS, INC. 2470 FARADAY Carlsbad, CA 92008 -7224 |
| Product Code | DNO |
| CFR Regulation Number | 862.3450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-07 |
| Decision Date | 1997-02-11 |
| Summary: | summary |