Cleared Traditional

K761241 - PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE
(FDA 510(k) Clearance)

Dec 1976
Decision
17d
Days
Class 1
Risk

K761241 is an FDA 510(k) clearance for the PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE. This device is classified as a Transport Systems, Anaerobic (Class I - General Controls, product code JTX).

Submitted by Gibco Laboratories Life Technologies, Inc. (Mchenry, US). The FDA issued a Cleared decision on December 30, 1976, 17 days after receiving the submission on December 13, 1976.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2900.

Submission Details

510(k) Number K761241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 1976
Decision Date December 30, 1976
Days to Decision 17 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code JTX — Transport Systems, Anaerobic
Device Class Class I - General Controls
CFR Regulation 21 CFR 866.2900