Cleared Traditional

K792058 - ENTERIC-TEK

K792058 is the FDA 510(k) clearance for ENTERIC-TEK by Flow Laboratories, Inc.. It is a Class 1 Microbiology device (product code JSS) cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K792058 · Flow Laboratories, Inc. · Microbiology device
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Jan 1980
Decision
88d
Days
Class 1
Risk

K792058 is an FDA 510(k) clearance for the ENTERIC-TEK. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by Flow Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 11, 1980 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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 Flow Laboratories, Inc. devices

Submission Details

510(k) Number K792058 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1979
Decision Date January 11, 1980
Days to Decision 88 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
14d faster than avg
Panel avg: 102d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSS Kit, Identification, Enterobacteriaceae
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JSS Kit, Identification, Enterobacteriaceae

All 20
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K792058.
MINITECK ENTERIC BROTH & ENTEROBACTER
K812286 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1981
SENSITITIRE AP60
K811765 · Gibco Laboratories Life Technologies, Inc. · Aug 1981
SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS
K811434 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1981
3M MICROBIAL PROFILE SYSTEM GRAM
K791789 · 3M Company · Nov 1979
AMS ENTEROBACTERIACEASE CARE
K791932 · Vitek Systems, Inc. · Nov 1979
CORD, ENTEROBACTERIACEAE BIOCHEMICAL
K782056 · Vitek Systems, Inc. · Jan 1979