Cleared Traditional

K800803 - NITRATE SWAB-RAPID TEST

K800803 is the FDA 510(k) clearance for NITRATE SWAB-RAPID TEST by Remel Co.. It is a Class 1 Microbiology device (product code JXB) cleared through the Traditional 510(k) pathway after a 89-day FDA review.

K800803 · Remel Co. · Microbiology device
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Jul 1980
Decision
89d
Days
Class 1
Risk

K800803 is an FDA 510(k) clearance for the NITRATE SWAB-RAPID TEST. Classified as Kit, Identification, Yeast (product code JXB), Class I - General Controls.

Submitted by Remel Co. (Mchenry, US). The FDA issued a Cleared decision on July 8, 1980 after a review of 89 days - a notably fast clearance 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: 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 Remel Co. devices

Submission Details

510(k) Number K800803 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1980
Decision Date July 08, 1980
Days to Decision 89 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
13d faster than avg
Panel avg: 102d · This submission: 89d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JXB Kit, Identification, Yeast
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 - JXB Kit, Identification, Yeast

Devices cleared under the same product code (JXB) and FDA review panel - the closest regulatory comparables to K800803.
VITEK YEAST BIOCHEMICAL CARD
K881925 · Vitek Systems, Inc. · Jun 1988
YEAST IDENT
K830286 · Analytical Products, Inc. · Apr 1983
MS-2 IDENTIFICATION SYSTEM
K802309 · Abbott Laboratories · Dec 1980
AMS YEAST BIOCHEMICAL CARD
K792231 · Vitek Systems, Inc. · Dec 1979
API 20C
K771008 · Analytical Products, Inc. · Aug 1977