Cleared Traditional

K955223 - SAS SPICER-EDWARDS 1 ANTISERUM

K955223 is the FDA 510(k) clearance for SAS SPICER-EDWARDS 1 ANTISERUM by Sa Scientific, Inc.. It is a Class 2 Microbiology device (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

Submission Details

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.

Device Classification

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 50
Devices cleared under the same product code (GNC) and FDA review panel - the closest regulatory comparables to K955223.
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
SAS SPICER-EDWARDS EN COMPLEX ANTISERUM
K955227 · Sa Scientific, Inc. · Feb 1996
SAS SPICER-EDWARDS L COMPLEX
K955228 · Sa Scientific, Inc. · Feb 1996
SAL SALMONELLA H Q ANTISERUM
K955195 · Sa Scientific, Inc. · Feb 1996