Cleared Traditional

CRYPTOSPORIDIUM TEST

K980354 · Techlab, Inc. · Microbiology
May 1998
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K980354 is an FDA 510(k) clearance for the CRYPTOSPORIDIUM TEST, a Cryptosporidium Spp. (Class II — Special Controls, product code MHJ), submitted by Techlab, Inc. (Blacksburg, US). The FDA issued a Cleared decision on May 18, 1998, 109 days after receiving the submission on January 29, 1998. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K980354 FDA.gov
FDA Decision Cleared SESE
Date Received January 29, 1998
Decision Date May 18, 1998
Days to Decision 109 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