PRECEPT CEFOPERAZONE— 510(k) K853596

Name: FDA 510(k) clearance K853596
Creator: U.S. Food and Drug Administration
Published: 1985-09-16

Substantially Equivalent

Austin Biological Laboratories

FDA 510(k) clearance K853596 for PRECEPT CEFOPERAZONE, Substantially Equivalent on 1985-09-16. Applicant: Austin Biological Laboratories. Device class: 2.

Clearance details

Applicant: Austin Biological Laboratories
Product code: Code LTW
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 1985-08-27
Decision date: 1985-09-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LTW

view all

K852613 — MIC-CONCEPT SYSTEM1985-09-20
K853273 — PRECEPT CEFTRIAXONE1985-09-16
K853685 — PRECEPT TM CARBENICILLIN1985-09-16
K853772 — PRECEPT METHICILLIN1985-09-16
K853684 — PRECEPT KANAMYCIN1985-09-13

More clearances from Austin Biological Laboratories

view all

K880511 — XACT NEISSERIA1988-08-25
K874727 — PRECEPT(TM) CIPROFLOXACIN1988-02-18
K870769 — AUSTIN NONFERMENTER KIT1987-04-03
K864069 — PRECEPT (TM) TICARCILLIN/CLAVULANIC ACID1986-11-13
K862446 — PRECEPT CEFTAZIDIME1986-07-11

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