Cleared Traditional

K781376 - STANDARDIZE TGCL & TGCH

K781376 is the FDA 510(k) clearance for STANDARDIZE TGCL & TGCH by American Monitor Corp.. It is a Class 1 Chemistry device (product code JTX) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K781376 · American Monitor Corp. · Chemistry device
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Sep 1978
Decision
36d
Days
Class 1
Risk

K781376 is an FDA 510(k) clearance for the STANDARDIZE TGCL & TGCH. Classified as Transport Systems, Anaerobic (product code JTX), Class I - General Controls.

Submitted by American Monitor Corp. (Mchenry, US). The FDA issued a Cleared decision on September 14, 1978 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2900 - the FDA in vitro diagnostics and chemistry 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 American Monitor Corp. devices

Submission Details

510(k) Number K781376 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 09, 1978
Decision Date September 14, 1978
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTX Transport Systems, Anaerobic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2900
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 - JTX Transport Systems, Anaerobic

Devices cleared under the same product code (JTX) and FDA review panel - the closest regulatory comparables to K781376.
ACUSON V328 AND C5432 TRANSDUCERS
K897151 · Acuson Corp. · Jul 1990
BIO-BAG ENVIRONMENTAL CHAMBER (A & B)
K791724 · Marion Laboratories, Inc. · Oct 1979
PRE-DUCED SURGI-SWAB & TRANSPORTER TUBE
K761241 · Gibco Laboratories Life Technologies, Inc. · Dec 1976
SPECIMEN COLLECTOR, ANAEROBIC
K760063 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Aug 1976