Cleared Traditional

K850308 - C.L.A.T.

K850308 is an FDA 510(k) clearance for C.L.A.T., manufactured by Pro-Lab, Inc.. The device is a Class 1 Microbiology device with product code JSK cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K850308 · Pro-Lab, Inc. · Microbiology device
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Mar 1985
Decision
57d
Days
Class 1
Risk

K850308 is an FDA 510(k) clearance for the C.L.A.T.. Classified as Supplement, Culture Media (product code JSK), Class I - General Controls.

Submitted by Pro-Lab, Inc. (Ontario Canada M5m 1c9, CA). The FDA issued a Cleared decision on March 20, 1985 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2450 - 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 Pro-Lab, Inc. devices

FDA 510(k) Submission Details - K850308

510(k) Number K850308 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1985
Decision Date March 20, 1985
Days to Decision 57 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
45d faster than avg
Panel avg: 102d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

JSK Device Classification - Class 1, General Controls

Product Code JSK Supplement, Culture Media
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2450
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 - JSK Supplement, Culture Media

All 65
Devices cleared under the same product code (JSK) and FDA review panel - the closest regulatory comparables to K850308.
YEAST DIALYSATE
K850301 · Pro-Lab, Inc. · Mar 1985
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K850307 · Pro-Lab, Inc. · Mar 1985
PRESTON CAMPYLOBACTER SELECTIVE SUPP
K840330 · Oxoid U.S.A., Inc. · May 1984
LEGIONELLA MWY SELECTIVE SUPPLEMENT
K840331 · Oxoid U.S.A., Inc. · May 1984
LEGIONELLA BMPA SELECTIVE SUPPLE
K840333 · Oxoid U.S.A., Inc. · May 1984