Tool · 510(k)

510(k) Predicate Finder

Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

Product Code: GRM FDA class 2

Antisera, All Groups, Salmonella Spp.

Microbiology

View full classification →

The Antisera, All Groups, Salmonella Spp. is a collection of antisera covering all serogroup specificities used in the laboratory serotyping of Salmonella species isolates. As an FDA Class 2 device, it carries moderate risk and requires 510(k) premarket notification to demonstrate substantial equivalence. Regulated under 21 CFR 866.3550 with product code GRM in the Microbiology specialty. No special flags apply to this device.

510(k) Clearances

50+ matches

K Number

Device Name

Decision Date

Decision

Applicant

K961948

SAS SALMONELLA O FACTOR 20 ANTISERUM

Jun 18, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K961954

SAS SALMONELLA H Z35 ANTISERUM

Jun 18, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K961951

SAS SALMONELLA O FACTOR 6 ANTISERUM

Jun 18, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K961964

SAS SALMONELLA O GROUP H FACTORS 14,24,25 ANTISERUM

Jun 18, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K961961

SAS SALMONELLA H F,G,T ANTISERUM

Jun 18, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K961958

SAS SALMONELLA H Z4 COMPLEX ANTISERUM

Jun 18, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K961963

SAS SALMONELLA O GROUP W FACTOR 45 ANTISERUM

Jun 18, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K961962

SAS SALMONELLA O GROUP V FACTOR 44 ANTISERUM

Jun 18, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K961953

SAS SALMONELA H Z24 ANTISERUM

Jun 18, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K961960

SAS SALMONELLA H Z4, Z24 ANTISERUM

Jun 18, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K961956

SAS SALMONELLA H G,M,Q ANTISERMU

Jun 18, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K961966

SAS SALMONELLA O GROUP X FACTOR 47 ANTISERUM

Jun 18, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K961949

SAS SALMONELLA O FACTOR 14 ANTISERUM

Jun 18, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K961957

SAS SALMONELLA H Z4, Z32 ANTISERUM

Jun 18, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K961955

SAS SALMONELLA H Z42 ANTISERUM

Jun 18, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K961950

SAS SALMONELLA O FACTOR 15 ANTISERUM &/OR O GROUP E2 FACTOR 15 ANTISERUM

Jun 18, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K961967

SAS SALMONELLA O POLY B ANTISERUM

Jun 18, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K961952

SAS SALMONELLA O FACTOR /O GROUP A FACTOR 2 ANTISERUMS

Jun 18, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960147

SAS SALMONELLA 0 GROUP E FACTORS 1,3,10,15,19,34 ANTISERUM

Mar 12, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960130

SAS SALMONELLA O GROUP Z FACTOR 50 ANTISERUM

Mar 12, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960129

SAS SALMONELLA O GROUP Y FACTOR 48 ANTISERUM

Mar 12, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960160

SAS SALMONELLA 0 GROUP M FACTOR 28 ANTISERUM

Mar 12, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960461

SAS SALMONELLA O GROUP R FACTOR 40 ANTISERUM

Mar 12, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960142

SAS SALMONELLA 0 FACTOR 23 ANTISERUM AND/OR SAS SLAMONELLA 0 GROUP G2 FACTOR 23 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960459

SAS SALMONELLA O GROUP S FACTOR 41 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960132

SAS SALMONELLA H U ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960125

SAS SALMONELLA O FACTOR 4 ANTISERUM &/OR SAS SALMONELLA O GROUP B FACTOR 4,5 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960458

SAS SALMONELLA O GROUP T FACTOR 42 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960123

SAS SALMONELLA O FACTOR 18 ANTISERUM &/OR SAS SALMONELLA O GROUP K FACTOR 18 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960124

SAS SALMONELLA 0 FACTOR 10 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP E1 FACTOR 10 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960126

SAS SALMONELLA O FACTOR 19 ANTISERUM &/OR SAS SALMONELLA O GROUP E4 FACTOR 19 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960149

SAS SALMONELLA 0 GROUP F FACTOR 11 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960127

SAS SALMONELLA O FACTOR 22 ANTISERUM &/OR SAS SALMONELLA O GROUP G1 FACTOR 22 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960136

SAS SALMONELLA H P ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960153

SAS SALOMNELLA 0 GROUP L FACTOR 21 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960135

SAS SALMONELLA H M ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960460

SAS SALMONELLA O FACTOR 46 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960134

SAS SALMONELLA 0 FACTOR 9 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP D FACTOR 9 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960150

SAS SALMONELLA 0 GROUP J FACTOR 17 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960163

SAS SALMONELLA 0 FACTOR FACTOR 5 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960462

SAS SALMONELLA O GROUP Q FACTOR 39 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960463

SAS SALMONELLA O GROUP U FACTOR 43 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960465

SAS SALMONELLA O GROUP P FACTOR 38 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960145

SAS SALMONELLA 0 FACTOR 27 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960162

SAS SALMONELLA 0 GROUP 0 FACTOR 35 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960140

SAS SALMONELLA 0 FACTOR ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C1 FACTOR 7 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960137

SAS SALMONELLA H Z10 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960152

SAS SALMONELLA 0 FACTOR 12 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960161

SAS SALMONELLA 0 GROUP N FACTOR 30 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

K960138

SAS SALMONELLA 0 FACTOR 8 ANTISERUM AND/OR SAS SALMONELLA 0 GROUP C2 FACTOR 9 ANTISERUM

Mar 06, 1996

Substantially Equivalent

SA SCIENTIFIC, INC.

What is a Predicate Device?

A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

Popular Product Codes

Commonly searched

DQA Oximeter DTB Permanent Pacemaker Electrode DXN System, Measurement, Blood-Pressure, Non-Invasive LLZ System, Image Processing, Radiological MNR Ventilatory Effort Recorder NQK Maggots, Medical OEI Drainage Catheter With Antibiotic PIB Diabetic Retinopathy Detection Device QAS Radiological Computer-Assisted Triage And Notification Software QFG Alternate Controller Enabled Insulin Infusion Pump