BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM— 510(k) K865021

Name: FDA 510(k) clearance K865021
Creator: U.S. Food and Drug Administration
Published: 1987-02-06

Substantially Equivalent

Bd Becton Dickinson Vacutainer Systems Preanalytic

FDA 510(k) clearance K865021 for BACTEC(R) NR-660 HIGH PERFORMANCE SYSTEM, Substantially Equivalent on 1987-02-06. Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic. Device class: 1.

Clearance details

Applicant: Bd Becton Dickinson Vacutainer Systems Preanalytic
Product code: Code JTA
Device class: Class 1
Regulation: 21 CFR 866.2560
Advisory panel: Microbiology
Date received: 1986-12-23
Decision date: 1987-02-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Franklin Lakes, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTA

view all

K954923 — BACTEC FUNGAL MEDIUM1996-11-21
K910835 — BACTEC NR-8601991-03-11
K853011 — BACTEC NR-730 BACTERIAL DETECTION SYSTEM1985-07-30
K842874 — RADIOMETRIC BLOOD CULTURE VIALS, AEROBE1984-09-12
K842279 — BECTEC NR-660 BACTERIAL DETECT SYS1984-07-20

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.