Cleared Traditional

K850194 - CAFFEIC ACID DISK

K850194 is an FDA 510(k) clearance for CAFFEIC ACID DISK, manufactured by Remel Co.. The device is a Class 1 Microbiology device with product code JSF cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K850194 · Remel Co. · Microbiology device
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Apr 1985
Decision
94d
Days
Class 1
Risk

K850194 is an FDA 510(k) clearance for the CAFFEIC ACID DISK. Classified as Culture Media, Single Biochemical Test (product code JSF), Class I - General Controls.

Submitted by Remel Co. (Lenexa, US). The FDA issued a Cleared decision on April 22, 1985 after a review of 94 days - within the typical 510(k) review window.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2320 - 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

FDA 510(k) Submission Details - K850194

510(k) Number K850194 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 1985
Decision Date April 22, 1985
Days to Decision 94 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
8d faster than avg
Panel avg: 102d · This submission: 94d
Pathway characteristics
Predicate-based equivalence.

JSF Device Classification - Class 1, General Controls

Product Code JSF Culture Media, Single Biochemical Test
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2320
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 - JSF Culture Media, Single Biochemical Test

All 62
Devices cleared under the same product code (JSF) and FDA review panel - the closest regulatory comparables to K850194.
BIOTIS DECARBOXYLASE MEDIA, ARGININE
K862396 · Otisville Biotech, Inc. · Jul 1986
BIOTIS DECARBOXYLASE MEDIA, LYSINE
K862397 · Otisville Biotech, Inc. · Jul 1986
BIOTIS DECARBOXYLASE MEDIA, ORNITHINE
K862398 · Otisville Biotech, Inc. · Jul 1986
ACETATE DIFFERENTIAL AGAR
K850545 · Hardy Media · Mar 1985
SIMMONS CITRATE AGAR
K850550 · Hardy Media · Mar 1985
CYSTINE TRYPTIC AGAR W/DEXTROSE
K844542 · bioMerieux, Inc. · Jan 1985