Cleared Traditional

K812451 - CAMPY THIOGLYCOLLATE (TUBE)

K812451 is the FDA 510(k) clearance for CAMPY THIOGLYCOLLATE (TUBE) by Granite Diagnostics, Inc.. It is a Class 1 Chemistry device (product code JSD) cleared through the Traditional 510(k) pathway after a 26-day FDA review.

K812451 · Granite Diagnostics, Inc. · Chemistry device
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Sep 1981
Decision
26d
Days
Class 1
Risk

K812451 is an FDA 510(k) clearance for the CAMPY THIOGLYCOLLATE (TUBE). Classified as Culture Media, Selective Broth (product code JSD), Class I - General Controls.

Submitted by Granite Diagnostics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 23, 1981 after a review of 26 days - a notably fast clearance cycle.

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

Submission Details

510(k) Number K812451 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1981
Decision Date September 23, 1981
Days to Decision 26 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 88d · This submission: 26d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JSD Culture Media, Selective Broth
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 - JSD Culture Media, Selective Broth

All 20
Devices cleared under the same product code (JSD) and FDA review panel - the closest regulatory comparables to K812451.
BACTEC DILUTING FLUID
K822330 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1982
DERMATOPHYTE TEST MEDIUM
K822131 · Granite Diagnostics, Inc. · Aug 1982
SELENITE BROTH
K820558 · American Laboratory Supply, Inc. · Mar 1982
SABOURAUD LIQUID, BROTH MODIFIED
K811326 · Acumedia Manufacturers, Inc. · May 1981
G N BROTH HAJNA
K791589 · Isle Media and Sterile Products, Inc. · Sep 1979
SELENITE CYSTINE BROTH
K791471 · Isle Media and Sterile Products, Inc. · Aug 1979