Cleared Traditional

K791607 - BETA-CELL

K791607 is the FDA 510(k) clearance for BETA-CELL by Biologics Intl., Inc.. It is a Class 1 Chemistry device (product code JSG) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K791607 · Biologics Intl., Inc. · Chemistry device
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Sep 1979
Decision
41d
Days
Class 1
Risk

K791607 is an FDA 510(k) clearance for the BETA-CELL. Classified as Culture Media, Non-selective And Non-differential (product code JSG), Class I - General Controls.

Submitted by Biologics Intl., Inc. (Mchenry, US). The FDA issued a Cleared decision on September 24, 1979 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2300 - the FDA in vitro diagnostics and chemistry 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 Biologics Intl., Inc. devices

Submission Details

510(k) Number K791607 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1979
Decision Date September 24, 1979
Days to Decision 41 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 88d · This submission: 41d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSG Culture Media, Non-selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2300
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 - JSG Culture Media, Non-selective And Non-differential

All 181
Devices cleared under the same product code (JSG) and FDA review panel - the closest regulatory comparables to K791607.
BRAIN HEART INFUSION AGAR 5% SHEEP BLOOD
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BRAIN HEART INFUSION AGAR
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SABOURAUD DEXTROSE AGAR
K791631 · Isle Media and Sterile Products, Inc. · Sep 1979
TRYPTIC SOY AGAR 5% SHEEP BLOOD
K791620 · American Laboratory Supply, Inc. · Sep 1979
COLUMBIA AGAR WITH5% SHEEP
K791622 · American Laboratory Supply, Inc. · Sep 1979
THIOGLYCOLLATE MEDIUM WITHOUT INDICATOR
K791542 · Isle Media and Sterile Products, Inc. · Sep 1979