Cleared Traditional

PREMIER CRYPTOSPORIDIUM

K982764 · Meridian Diagnostics, Inc. · Microbiology
Dec 1998
Decision
119d
Days
Class 2
Risk

About This 510(k) Submission

K982764 is an FDA 510(k) clearance for the PREMIER CRYPTOSPORIDIUM, a Cryptosporidium Spp. (Class II — Special Controls, product code MHJ), submitted by Meridian Diagnostics, Inc. (Cincinnati, US). The FDA issued a Cleared decision on December 3, 1998, 119 days after receiving the submission on August 6, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K982764 FDA.gov
FDA Decision Cleared SESE
Date Received August 06, 1998
Decision Date December 03, 1998
Days to Decision 119 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MHJ — Cryptosporidium Spp.
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.3220