Cleared Traditional

K943400 - SAS SALMONELLA H D ANTISERUM

K943400 is an FDA 510(k) clearance for SAS SALMONELLA H D ANTISERUM, manufactured by Sa Scientific, Inc.. The device is a Class 2 Microbiology device with product code GRM cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K943400 · Sa Scientific, Inc. · Microbiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1994
Decision
111d
Days
Class 2
Risk

K943400 is an FDA 510(k) clearance for the SAS SALMONELLA H D ANTISERUM. Classified as Antisera, All Groups, Salmonella Spp. (product code GRM), Class II - Special Controls.

Submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on November 2, 1994 after a review of 111 days - within the typical 510(k) review window.

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 Sa Scientific, Inc. devices

FDA 510(k) Submission Details - K943400

510(k) Number K943400 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1994
Decision Date November 02, 1994
Days to Decision 111 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
9d slower than avg
Panel avg: 102d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GRM Device Classification - Class 2, Special Controls

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 K943400.
SAS SALMONELLA O POLY POSITIVE ANTISERUM
K952133 · Sa Scientific, Inc. · Jul 1995
SAS SALMONELLA H POLY POSITIVE ANTISERUM
K952134 · Sa Scientific, Inc. · Jul 1995
SAS SALMONELLA H B ANTISERUM
K951069 · Sa Scientific, Inc. · Jun 1995
WELLCOLEX COLOUR SALMONELLA TEST ZL 50
K890146 · Wellcome Diagnostics · Feb 1989
BACTIGEN SALMONELLA-SHIGELLA TEST
K870813 · Armkel, LLC · Apr 1987
SALMONELLA I.D.
K821338 · Analytical Products, Inc. · May 1982