MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST— 510(k) K863485

Name: FDA 510(k) clearance K863485
Creator: U.S. Food and Drug Administration
Published: 1986-09-17

Substantially Equivalent

Marion Laboratories, Inc.

FDA 510(k) clearance K863485 for MODIFICATION OF CDT(TM) CLOSTRIDIUM TEST, Substantially Equivalent on 1986-09-17. Applicant: Marion Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Marion Laboratories, Inc.
Product code: Code LLH
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1986-09-09
Decision date: 1986-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Kansas City, MI, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LLH

view all

K193490 — SensiTox C. difficile Toxin Test2021-07-08
K102242 — OSOM C. DIFFICILE TOXIN A/B TEST2010-12-21
K091109 — XPERT C. DIFFICILE2009-07-09
K090239 — PROGASTRO CD ASSAY2009-04-16
K082499 — C. DIFF QUIK CHEK COMPLETE2009-03-26

More clearances from Marion Laboratories, Inc.

view all

K883391 — POLYMER ADHESIVE BANDAGE1989-03-23
K875182 — MODIFIED LABELING FOR TOXI-LAB THC SCREEN1988-07-05
K875181 — MODIFIED LABELING FOR TOXI-LAB BROAD SPECTRUM1988-05-27
K874554 — ENVICLUSIVE (TM)1988-03-11
K874551 — ENVINET(TM)1988-01-22

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