Cleared Traditional

K920975 - BACTIDROP CALCOFLUOR WHITE

K920975 is the FDA 510(k) clearance for BACTIDROP CALCOFLUOR WHITE by Remel Co.. It is a Class 1 Pathology device (product code JTS) cleared through the Traditional 510(k) pathway after a 99-day FDA review.

K920975 · Remel Co. · Pathology device
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Jun 1992
Decision
99d
Days
Class 1
Risk

K920975 is an FDA 510(k) clearance for the BACTIDROP CALCOFLUOR WHITE. Classified as Stains, Microbiologic (product code JTS), Class I - General Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on June 9, 1992 after a review of 99 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Pathology review framework, consistent with the majority of Class II 510(k) submissions.

View all Remel Co. devices

Submission Details

510(k) Number K920975 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 02, 1992
Decision Date June 09, 1992
Days to Decision 99 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d slower than avg
Panel avg: 77d · This submission: 99d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTS Stains, Microbiologic
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 - JTS Stains, Microbiologic

All 17
Devices cleared under the same product code (JTS) and FDA review panel - the closest regulatory comparables to K920975.
CALCOFLUOR WHITE STAIN KIT
K960090 · Remel Co. · Mar 1996
BACTIDROP CALCOFLUOR WHITE
K960095 · Remel Co. · Mar 1996
BACTIDROP KOH (10%)
K920970 · Remel Co. · Jun 1992
BACTIDROP INDIA INK
K920976 · Remel Co. · Jun 1992
CALCOFLUOR WHITE STAIN KIT
K880718 · Remel Co. · Mar 1988
GRAM CRYSTAL VIOLET/IODINE/ACETON ALCHL DECLR/SAFR
K873413 · Lakewood Biochemical Co., Inc. · Oct 1987