Cleared Traditional

TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS

K955755 · Trend Scientific, Inc. · Microbiology
Jul 1996
Decision
204d
Days
Class 2
Risk

About This 510(k) Submission

K955755 is an FDA 510(k) clearance for the TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS, a Cryptosporidium Spp. (Class II — Special Controls, product code MHJ), submitted by Trend Scientific, Inc. (New Brighton, US). The FDA issued a Cleared decision on July 11, 1996, 204 days after receiving the submission on December 20, 1995. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3220.

Submission Details

510(k) Number K955755 FDA.gov
FDA Decision Cleared SESE
Date Received December 20, 1995
Decision Date July 11, 1996
Days to Decision 204 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