Cleared Traditional

K811765 - SENSITITIRE AP60

K811765 is the FDA 510(k) clearance for SENSITITIRE AP60 by Gibco Laboratories Life Technologies, Inc.. It is a Class 1 Microbiology device (product code JSS) cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K811765 · Gibco Laboratories Life Technologies, Inc. · Microbiology device
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Aug 1981
Decision
52d
Days
Class 1
Risk

K811765 is an FDA 510(k) clearance for the SENSITITIRE AP60. Classified as Kit, Identification, Enterobacteriaceae (product code JSS), Class I - General Controls.

Submitted by Gibco Laboratories Life Technologies, Inc. (Walker, US). The FDA issued a Cleared decision on August 13, 1981 after a review of 52 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 Gibco Laboratories Life Technologies, Inc. devices

Submission Details

510(k) Number K811765 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 1981
Decision Date August 13, 1981
Days to Decision 52 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
50d faster than avg
Panel avg: 102d · This submission: 52d
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 23
Devices cleared under the same product code (JSS) and FDA review panel - the closest regulatory comparables to K811765.
UREA-PDA DISK
K830396 · Remel Co. · Mar 1983
SYSTEK #1 EIKEN
K813164 · Syn-Kit, Inc. · Dec 1981
MINITECK ENTERIC BROTH & ENTEROBACTER
K812286 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Oct 1981
SCEPTOR ID GRAM NEGATIVE MIC/ID PANELS
K811434 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1981
ENTERIC-TEK
K792058 · Flow Laboratories, Inc. · Jan 1980
3M MICROBIAL PROFILE SYSTEM GRAM
K791789 · 3M Company · Nov 1979