Cleared Traditional

K834090 - TITERTEK ENTEROBAC*

K834090 is an FDA 510(k) clearance for TITERTEK ENTEROBAC*, manufactured by Flow Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JSS cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K834090 · Flow Laboratories, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1984
Decision
46d
Days
Class 1
Risk

K834090 is an FDA 510(k) clearance for the TITERTEK ENTEROBAC*. 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 13, 1984 after a review of 46 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.

FDA 510(k) Submission Details - K834090

510(k) Number K834090 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 1983
Decision Date January 13, 1984
Days to Decision 46 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
56d faster than avg
Panel avg: 102d · This submission: 46d
Pathway characteristics
Predicate-based equivalence.

JSS Device Classification - Class 1, General Controls

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 48
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K834090.
LYFO-KWIK OMI KIT
K851978 · Micro-Bio-Logics · Jun 1985
IDS RAPID E PLUS SYSTEM
K852110 · Innovative Diagnostic Systems, Inc. · Jun 1985
RIM-UREA
K843571 · Austin Biological Laboratories · Oct 1984
FLUOR-B. FRAG. DIRECT FLUORESCENT ANTI
K833612 · Petra Biomedical Products, Inc. · Dec 1983
FLUOR-B MEL A DIRECT FLUORESCENT ANTI
K833613 · Petra Biomedical Products, Inc. · Dec 1983
SPECTRUM-10
K831672 · Austin Biological Laboratories · Jun 1983
K834090 · TITERTEK ENTEROBAC*
Download PDF Flow Laboratories, In…