Cleared Traditional

K955223 - SAS SPICER-EDWARDS 1 ANTISERUM

K955223 is an FDA 510(k) clearance for SAS SPICER-EDWARDS 1 ANTISERUM, manufactured by Sa Scientific, Inc.. The device is a Class 2 Microbiology device with product code GNC cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K955223 · Sa Scientific, Inc. · Microbiology device
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Feb 1996
Decision
91d
Days
Class 2
Risk

K955223 is an FDA 510(k) clearance for the SAS SPICER-EDWARDS 1 ANTISERUM. Classified as Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp. (product code GNC), Class II - Special Controls.

Submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on February 13, 1996 after a review of 91 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 - K955223

510(k) Number K955223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 14, 1995
Decision Date February 13, 1996
Days to Decision 91 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
11d faster than avg
Panel avg: 102d · This submission: 91d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GNC Device Classification - Class 2, Special Controls

Product Code GNC Antigens, Febrile, Slide And Tube, 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 - GNC Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp.

All 58
Devices cleared under the same product code (GNC) and FDA review panel - the closest regulatory comparables to K955223.
VISTA ANTIGEN SALMONELLA H B
K972391 · Lee Laboratories, Inc. · Aug 1997
VISTA ANTIGEN SALMONELLA H A
K972392 · Lee Laboratories, Inc. · Aug 1997
VISTA ANTIGEN SALMONELLA O GROUP D
K972395 · Lee Laboratories, Inc. · Aug 1997
SAS SPICER-EDWARDS 2 ANTISERUM
K955224 · Sa Scientific, Inc. · Feb 1996
SAS SPICER-EDWARDS 3 ANTISERUM
K955225 · Sa Scientific, Inc. · Feb 1996
SAS SPICER-EDWARDS 4 ANTISERUM
K955226 · Sa Scientific, Inc. · Feb 1996