Cleared Traditional

K860795 - SPOTTEST CALCOFLUOR WHITE REAGENT

K860795 is an FDA 510(k) clearance for SPOTTEST CALCOFLUOR WHITE REAGENT, manufactured by Difco Laboratories, Inc.. The device is a Class 1 Pathology device with product code LED cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K860795 · Difco Laboratories, Inc. · Pathology device
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Mar 1986
Decision
8d
Days
Class 1
Risk

K860795 is an FDA 510(k) clearance for the SPOTTEST CALCOFLUOR WHITE REAGENT. Classified as Stains, Chemical Solution (product code LED), Class I - General Controls.

Submitted by Difco Laboratories, Inc. (Detroit, US). The FDA issued a Cleared decision on March 12, 1986 after a review of 8 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.1850 - the FDA pathology 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 - K860795

510(k) Number K860795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 1986
Decision Date March 12, 1986
Days to Decision 8 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 78d · This submission: 8d
Pathway characteristics
Predicate-based equivalence.

LED Device Classification - Class 1, General Controls

Product Code LED Stains, Chemical Solution
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.1850
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 - LED Stains, Chemical Solution

All 15
Devices cleared under the same product code (LED) and FDA review panel - the closest regulatory comparables to K860795.
SLIVASURE
K051409 · Scandinavian Formulas, Inc. · Aug 2005
SST SALIVA SUPPORTING TABLETS
K023046 · Sinclair Pharmaceuticals, Ltd. · Dec 2002
PANOPTIKON
K860316 · Cytocolor, Inc. · Feb 1986
NEUTROCOLOR
K860317 · Cytocolor, Inc. · Feb 1986
MEGACOLOR
K860319 · Cytocolor, Inc. · Feb 1986
GRANULOCOLOR
K860320 · Cytocolor, Inc. · Feb 1986
K860795 · SPOTTEST CALCOFLUOR WHITE REAGENT
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