Cleared Traditional

K910438 - DIPSTICK SALMONELLA

K910438 is the FDA 510(k) clearance for DIPSTICK SALMONELLA by Ampcor, Inc.. It is a Class 2 Microbiology device (product code GRM) cleared through the Traditional 510(k) pathway after a 225-day FDA review.

K910438 · Ampcor, Inc. · Microbiology device
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Sep 1991
Decision
225d
Days
Class 2
Risk

K910438 is an FDA 510(k) clearance for the DIPSTICK SALMONELLA. Classified as Antisera, All Groups, Salmonella Spp. (product code GRM), Class II - Special Controls.

Submitted by Ampcor, Inc. (Bridgeport, US). The FDA issued a Cleared decision on September 13, 1991 after a review of 225 days - an extended review cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.3550 - 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 Ampcor, Inc. devices

Submission Details

510(k) Number K910438 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1991
Decision Date September 13, 1991
Days to Decision 225 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
123d slower than avg
Panel avg: 102d · This submission: 225d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GRM Antisera, All Groups, Salmonella Spp.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 866.3550
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Microbiology devices follow this clearance model.

Regulatory Peers - GRM Antisera, All Groups, Salmonella Spp.

All 66
Devices cleared under the same product code (GRM) and FDA review panel - the closest regulatory comparables to K910438.
SAS SALMONELLA H POLY POSITIVE ANTISERUM
K952134 · Sa Scientific, Inc. · Jul 1995
SAS SALMONELLA H B ANTISERUM
K951069 · Sa Scientific, Inc. · Jun 1995
SAS SALMONELLA H D ANTISERUM
K943400 · Sa Scientific, Inc. · Nov 1994
BACTIGEN SALMONELLA-SHIGELLA TEST
K870813 · Armkel, LLC · Apr 1987
SALMONELLA I.D.
K821338 · Analytical Products, Inc. · May 1982