Cleared Traditional

K812911 - BCYE MEDIUM

K812911 is an FDA 510(k) clearance for BCYE MEDIUM, manufactured by Gibco Laboratories Life Technologies, Inc.. The device is a Class 1 Microbiology device with product code JSE cleared through the Traditional 510(k) pathway after a 18-day FDA review.

K812911 · Gibco Laboratories Life Technologies, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1981
Decision
18d
Days
Class 1
Risk

K812911 is an FDA 510(k) clearance for the BCYE MEDIUM. Classified as Culture Media, Multiple Biochemical Test (product code JSE), Class I - General Controls.

Submitted by Gibco Laboratories Life Technologies, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 6, 1981 after a review of 18 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - 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 - K812911

510(k) Number K812911 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 19, 1981
Decision Date November 06, 1981
Days to Decision 18 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
84d faster than avg
Panel avg: 102d · This submission: 18d
Pathway characteristics
Predicate-based equivalence.

JSE Device Classification - Class 1, General Controls

Product Code JSE Culture Media, Multiple Biochemical Test
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSE Culture Media, Multiple Biochemical Test

All 52
Devices cleared under the same product code (JSE) and FDA review panel - the closest regulatory comparables to K812911.
CULTURE MEDIA, NON-SELECTIVE/DIFFER
K820842 · Blue Ridge Media Co. · Apr 1982
#4004 TRIPLE SUGAR IRON AGAR SLANTS-TUBE
K820810 · Biomedica, Inc. · Apr 1982
SUCROSE
K820214 · Dms Laboratories · Feb 1982
ONPX-INDOL MEDIUM MICROTUBES
K812466 · Carr Microbiologicals · Sep 1981
PGUA-INDOL MICROTUBE
K812467 · Carr Microbiologicals · Sep 1981
RAPID FERMENTATION AGAR (RFA)
K800734 · Remel Co. · May 1980
K812911 · BCYE MEDIUM
Download PDF Gibco Laboratories Li…