Cleared Traditional

K770840 - PRE-REDUCED ANAEROBIC MEDIA

K770840 is an FDA 510(k) clearance for PRE-REDUCED ANAEROBIC MEDIA, manufactured by Gibco Laboratories Life Technologies, Inc.. The device is a Class 1 Microbiology device with product code JSL cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K770840 · Gibco Laboratories Life Technologies, Inc. · Microbiology device
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Jun 1977
Decision
30d
Days
Class 1
Risk

K770840 is an FDA 510(k) clearance for the PRE-REDUCED ANAEROBIC MEDIA. Classified as Culture Media, Anaerobic Transport (product code JSL), Class I - General Controls.

Submitted by Gibco Laboratories Life Technologies, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 8, 1977 after a review of 30 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2390 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Gibco Laboratories Life Technologies, Inc. devices

FDA 510(k) Submission Details - K770840

510(k) Number K770840 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 09, 1977
Decision Date June 08, 1977
Days to Decision 30 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 102d · This submission: 30d
Pathway characteristics
Predicate-based equivalence.

JSL Device Classification - Class 1, General Controls

Product Code JSL Culture Media, Anaerobic Transport
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2390
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - JSL Culture Media, Anaerobic Transport

Devices cleared under the same product code (JSL) and FDA review panel - the closest regulatory comparables to K770840.
COPAN VENTURI TRANSYSTEM AMIES MEDIUM WITH CHARCOAL
K972449 · Copan Italia Spa · Aug 1997
ANAEROBIC TRANSPORT MEDIUM
K841220 · Anaerobe Systems · Apr 1984
ANA TRANS TUBE & SWABS STERILE PACK
K834357 · Anaerobe Systems · Jan 1984
PRE-DUCED CULTURE MEDIA
K770650 · Gibco Laboratories Life Technologies, Inc. · Apr 1977