Cleared Traditional

K802626 - ANAIROBE-TEK

K802626 is an FDA 510(k) clearance for ANAIROBE-TEK, manufactured by Flow Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JSP cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K802626 · Flow Laboratories, Inc. · Microbiology device
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Nov 1980
Decision
20d
Days
Class 1
Risk

K802626 is an FDA 510(k) clearance for the ANAIROBE-TEK. Classified as Kit, Anaerobic Identification (product code JSP), Class I - General Controls.

Submitted by Flow Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 12, 1980 after a review of 20 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 - K802626

510(k) Number K802626 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1980
Decision Date November 12, 1980
Days to Decision 20 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
82d faster than avg
Panel avg: 102d · This submission: 20d
Pathway characteristics
Predicate-based equivalence.

JSP Device Classification - Class 1, General Controls

Product Code JSP Kit, Anaerobic Identification
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 - JSP Kit, Anaerobic Identification

All 17
Devices cleared under the same product code (JSP) and FDA review panel - the closest regulatory comparables to K802626.
API ANAIDENT
K831032 · Analytical Products, Inc. · May 1983
ANAEROBE MIC/ID TEMPLATE, & TAXONOMY
K830964 · Bd Becton Dickinson Vacutainer Systems Preanalytic · May 1983
IDA RAPID O2A SYSTEM
K820483 · Innovative Diagnostic Systems, Inc. · Mar 1982
TEST PANEL FOR PRESUMP. ID/BACT. ORG
K801547 · Micro-Media Systems, Inc. · Sep 1980
API 20A
K771616 · Analytical Products, Inc. · Sep 1977
K802626 · ANAIROBE-TEK
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