Cleared Special

PRIMA SYSTEM - OLD, BARTELS ELISA - NEW

K990664 · Intracel Corp. · Microbiology
Mar 1999
Decision
30d
Days
Class 1
Risk

About This 510(k) Submission

K990664 is an FDA 510(k) clearance for the PRIMA SYSTEM - OLD, BARTELS ELISA - NEW, a Reagents, Clostridium Difficile Toxin (Class I — General Controls, product code LLH), submitted by Intracel Corp. (Rockville, US). The FDA issued a Cleared decision on March 31, 1999, 30 days after receiving the submission on March 1, 1999. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K990664 FDA.gov
FDA Decision Cleared SESE
Date Received March 01, 1999
Decision Date March 31, 1999
Days to Decision 30 days
Submission Type Special
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code LLH — Reagents, Clostridium Difficile Toxin
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660