Cleared Traditional

K810961 - CAMPYLOBACTER MED. (PLATE)

K810961 is an FDA 510(k) clearance for CAMPYLOBACTER MED. (PLATE), manufactured by Granite Diagnostics, Inc.. The device is a Class 1 Toxicology device with product code JSJ cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K810961 · Granite Diagnostics, Inc. · Toxicology device
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May 1981
Decision
26d
Days
Class 1
Risk

K810961 is an FDA 510(k) clearance for the CAMPYLOBACTER MED. (PLATE). Classified as Culture Media, Selective And Non-differential (product code JSJ), Class I - General Controls.

Submitted by Granite Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 5, 1981 after a review of 26 days - a notably fast clearance cycle.

This device falls under the Toxicology FDA review panel, regulated under 21 CFR 866.2360 - the FDA toxicology 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 Granite Diagnostics, Inc. devices

FDA 510(k) Submission Details - K810961

510(k) Number K810961 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 09, 1981
Decision Date May 05, 1981
Days to Decision 26 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
61d faster than avg
Panel avg: 87d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

JSJ Device Classification - Class 1, General Controls

Product Code JSJ Culture Media, Selective And Non-differential
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2360
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 - JSJ Culture Media, Selective And Non-differential

All 271
Devices cleared under the same product code (JSJ) and FDA review panel - the closest regulatory comparables to K810961.
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SCHAEDLER AGAR
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BRUCELLA AGAR
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COLUMBIA CNA AGAR
K811137 · Acumedia Manufacturers, Inc. · May 1981
BRILLIANT GREEN BILE BROTH 2%
K811057 · Acumedia Manufacturers, Inc. · Apr 1981