Cleared Traditional

K936021 - BACTICARD STREP

K936021 is the FDA 510(k) clearance for BACTICARD STREP by Remel Co.. It is a Class 1 Microbiology device (product code JTO) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K936021 · Remel Co. · Microbiology device
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May 1994
Decision
154d
Days
Class 1
Risk

K936021 is an FDA 510(k) clearance for the BACTICARD STREP. Classified as Discs, Strips And Reagents, Microorganism Differentiation (product code JTO), Class I - General Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on May 20, 1994 after a review of 154 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2660 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Microbiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Remel Co. devices

Submission Details

510(k) Number K936021 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 17, 1993
Decision Date May 20, 1994
Days to Decision 154 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 102d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JTO Discs, Strips And Reagents, Microorganism Differentiation
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - JTO Discs, Strips And Reagents, Microorganism Differentiation

All 144
Devices cleared under the same product code (JTO) and FDA review panel - the closest regulatory comparables to K936021.
M. CAT BUTYRATE DISK
K960996 · Hardy Diagnostics · Apr 1996
DRYSLIDE CARTARRHALIS
K954783 · Difco Laboratories, Inc. · Feb 1996
DISPENS-O-DISC(TM) NITROCEFIN
K941016 · Difco Laboratories, Inc. · Jun 1994
BACTICARD E. COLI
K934986 · Remel Co. · Feb 1994
PYR TEST KIT
K931865 · Hardy Diagnostics · Dec 1993
BACTICARD STREP
K933514 · Remel Co. · Oct 1993