Cleared Traditional

K972030 - STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS
(FDA 510(k) Clearance)

K972030 · Oxoid , Ltd. · Microbiology
Sep 1997
Decision
98d
Days
Class 1
Risk

K972030 is an FDA 510(k) clearance for the STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUS. This device is classified as a Kit, Screening, Staphylococcus Aureus (Class I — General Controls, product code JWX).

Submitted by Oxoid , Ltd. (Basingstoke, GB). The FDA issued a Cleared decision on September 8, 1997, 98 days after receiving the submission on June 2, 1997.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K972030 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 1997
Decision Date September 08, 1997
Days to Decision 98 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement

Device Classification

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