BBLCRYSTAL GRAM-POSITIVE ID SYSTEM— 510(k) K961968

Name: FDA 510(k) clearance K961968
Creator: U.S. Food and Drug Administration
Published: 1997-02-04

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K961968 for BBLCRYSTAL GRAM-POSITIVE ID SYSTEM, Substantially Equivalent on 1997-02-04. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code LQL
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1996-05-20
Decision date: 1997-02-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cockeysville, MD, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LQL

view all

K972576 — GRAM POSITIVE AUTOIDENTIFICATION PLATES, SENSITITRE AP901998-01-22
K961730 — RAPID GRAM-POSITIVE ID SYSTEM1997-02-04
K952095 — VITEK GRAM POSITIVE IDENTIFICATION CARD (GPI)1996-03-12
K925916 — VITEK RAPID CALL-GRAM POSITIVE IDENTIFICATION CARD1993-03-23
K910304 — RAPID CORYNE SYST/IDENTIF OF CORYNEFORM BACTERIA1991-07-26

More clearances from Bd Becton Dickinson Vacutainer Systems Preanalytic

view all

K003062 — BACTEC MGIT 960 SIR KITS2001-06-06
K003553 — 0.9% SODIUM CHLORIDE INJECTION, USP BD PRE-FILLED FLUSH SYRINGE2001-03-21
K003461 — BD VACUTAINER PASSIVE SHIELDING BLOOD COLLECTION NEEDLE2001-02-01
K002938 — B-D ULTRA-FINE III PEN NEEDLE; MODEL 31G X 3/162000-11-29
K001364 — BD DIRECTIGEN FLU A+B2000-06-28

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