TOBRAMYCIN REAGENT TEST KIT— 510(k) K813391

Substantially Equivalent

Beckman Instruments, Inc.

FDA 510(k) clearance K813391 for TOBRAMYCIN REAGENT TEST KIT, Substantially Equivalent on 1981-12-18. Applicant: Beckman Instruments, Inc..

Clearance details

Applicant: Beckman Instruments, Inc.
Product code: Code LKB
Advisory panel: Unknown
Date received: 1981-12-03
Decision date: 1981-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code LKB

product code LKB

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.