OPUS(R) TOBRAMYCIN— 510(k) K911940

Substantially Equivalent

Pb Diagnostic Systems, Inc.

FDA 510(k) clearance K911940 for OPUS(R) TOBRAMYCIN, Substantially Equivalent on 1991-07-01. Applicant: Pb Diagnostic Systems, Inc.. Device class: 2.

Clearance details

Applicant: Pb Diagnostic Systems, Inc.
Product code: Code LCR
Device class: Class 2
Regulation: 21 CFR 862.3900
Advisory panel: Clinical Toxicology
Date received: 1991-05-01
Decision date: 1991-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Westwood, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LCR

K060998 — QMS TOBRAMYCIN2006-07-21
K974029 — ACS TOBRAMYCIN1998-02-12
K962818 — TOBRAMYCIN FLEX REAGENT CARTRIDGE1996-09-13
K952568 — BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT1995-08-08
K911613 — VAR AURAL GROM AG/S9,SD8.00.28.5/0.2 NS/S/6823 1.41991-06-28

More clearances from Pb Diagnostic Systems, Inc.

K940507 — OPUS FT4 TEST SYSTEM1994-07-28
K934762 — OPUS PROCAINAMIDE TEST SYSTEM1994-07-20
K933389 — OPUS CMV-G1994-06-28
K934137 — OPUS(R) SEROLOGY CONTROLS, MODIFICATION1994-03-07
K935229 — OPUS DIGITOXIN1993-12-22

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