IMIPENEM SUSCEPTIBILITY POWDER— 510(k) K855071

Name: FDA 510(k) clearance K855071
Creator: U.S. Food and Drug Administration
Published: 1986-03-06

Substantially Equivalent

Merck, Sharp & Dohme

FDA 510(k) clearance K855071 for IMIPENEM SUSCEPTIBILITY POWDER, Substantially Equivalent on 1986-03-06. Applicant: Merck, Sharp & Dohme. Device class: 2.

Clearance details

Applicant: Merck, Sharp & Dohme
Product code: Code JTT
Device class: Class 2
Regulation: 21 CFR 866.1640
Advisory panel: Microbiology
Date received: 1985-12-19
Decision date: 1986-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: West Point, PA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JTT

view all

K983310 — SENSITITRE 18-24 HOUR SUSCEPTIBILITY PLATES WITH SPARFLOXACIN1998-12-17
K935805 — PASCO MIC AND MIC/ID PANELS1994-06-13
K895362 — BACTEC PYRAZINAMIDE SUSCEPTIBILITY TEST1989-12-01
K880574 — MODIFIED IMIPENEM SUSCEPTIBILITY POWDER1988-05-04
K872081 — CIPRO (TM) DIAGNOSTIC POWDER1987-06-15

More clearances from Merck, Sharp & Dohme

view all

K864442 — NORFLOXACIN SUSCEPTIBILITY POWDER1986-12-11
K760605 — LIGHTCAST II CARBIDE BLADE1976-10-05

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