Cleared Traditional

REMEL STAPH LATEX KIT

K964315 · Remel, L.P. · Microbiology
Feb 1997
Decision
101d
Days
Class 1
Risk

About This 510(k) Submission

K964315 is an FDA 510(k) clearance for the REMEL STAPH LATEX KIT, a Kit, Screening, Staphylococcus Aureus (Class I — General Controls, product code JWX), submitted by Remel, L.P. (Augusta, US). The FDA issued a Cleared decision on February 7, 1997, 101 days after receiving the submission on October 29, 1996. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K964315 FDA.gov
FDA Decision Cleared SESE
Date Received October 29, 1996
Decision Date February 07, 1997
Days to Decision 101 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code JWX — Kit, Screening, Staphylococcus Aureus
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660