The following data is part of a premarket notification filed by Beckman Instruments, Inc. with the FDA for Beckman Array Tobramycin (tob) Reagent.
| Device ID | K952568 |
| 510k Number | K952568 |
| Device Name: | BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT |
| Classification | Fluorescent Immunoassay, Tobramycin |
| Applicant | BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. BOX 8000 Brea, CA 92821 -6208 |
| Contact | Don W Hart |
| Correspondent | Don W Hart BECKMAN INSTRUMENTS, INC. 200 SOUTH KRAEMER BLVD. BOX 8000 Brea, CA 92821 -6208 |
| Product Code | LCR |
| CFR Regulation Number | 862.3900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-06-05 |
| Decision Date | 1995-08-08 |