Submission Details
| 510(k) Number | K952568 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 05, 1995 |
| Decision Date | August 08, 1995 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Toxicology (TX) |
| Summary | Summary PDF |
Cleared
Traditional
BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT
Aug 1995
Decision
64d
Days
Class 2
Risk
About This 510(k) Submission
K952568 is an FDA 510(k) clearance for the BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT, a Fluorescent Immunoassay, Tobramycin (Class II — Special Controls, product code LCR), submitted by Beckman Instruments, Inc. (Brea, US). The FDA issued a Cleared decision on August 8, 1995, 64 days after receiving the submission on June 5, 1995. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3900.
Device Classification
| Product Code | LCR — Fluorescent Immunoassay, Tobramycin |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.3900 |
Manufacturer
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