Cleared Traditional

PROLEX (STREPTOCCAL GROUPING LATEX KIT)

K934383 · Pro-Lab, Inc. · Microbiology
Jan 1995
Decision
505d
Days
Class 1
Risk

About This 510(k) Submission

K934383 is an FDA 510(k) clearance for the PROLEX (STREPTOCCAL GROUPING LATEX KIT), a Antisera, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTZ), submitted by Pro-Lab, Inc. (Richmond Hill, Ontario, CA). The FDA issued a Cleared decision on January 27, 1995, 505 days after receiving the submission on September 9, 1993. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K934383 FDA.gov
FDA Decision Cleared SESE
Date Received September 09, 1993
Decision Date January 27, 1995
Days to Decision 505 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

Product Code GTZ — Antisera, All Groups, Streptococcus Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3740

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