Medical Device Manufacturer · US , San Antonio , TX

Sa Scientific, Inc.

199 submissions · 199 cleared · Since 1993
199
Total
199
Cleared
0
Denied

Sa Scientific, Inc. — FDA 510(k) Submissions

Sa Scientific, Inc. has submitted 199 FDA 510(k) premarket notifications since 1993, of which 199 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Antisera, All Groups, Salmonella Spp., Antigens, Febrile, Slide And Tube, All Groups, Salmonella Spp., Antisera, All Types, Shigella Spp., Visual, Pregnancy Hcg, Prescription Use, Antigens (febrile), Agglutination, Brucella Spp. . Use the specialty filter in the sidebar to narrow results.

199 devices
1–25 of 199
SAS FLUALERT A&B, SAS INFLUENZA A TEST
K100227 · PSZ Devices Detecting... · Microbiology
Feb 2010 28d
SAS INFLUENZA A & B TEST
K080380 · PSZ Devices Detecting... · Microbiology
Jul 2009 526d
SAS INFLUENZA B TEST
K041439 · PSZ Devices Detecting... · Microbiology
Jul 2004 51d
SAS INFLUENZA A TEST
K041441 · PSZ Devices Detecting... · Microbiology
Jul 2004 51d
SAS RSV CONTROL KIT
K030628 · JJX Single (specified)... · Chemistry
Mar 2003 18d
SAS RSV TEST
K022845 · GQG Antigen, Cf (including Cf... · Microbiology
Jan 2003 155d
SAS BLOOD/SERUM/URINE/URINE HCG
K022683 · JHI Visual, Pregnancy Hcg,... · Chemistry
Dec 2002 126d
SAS STREPALERT
K023270 · GTY Antigens, All Groups,... · Microbiology
Oct 2002 16d
SAS VALUE HCG
K020438 · JHI Visual, Pregnancy Hcg,... · Chemistry
Mar 2002 25d
SAS STREPALERT
K013379 · GTY Antigens, All Groups,... · Microbiology
Dec 2001 61d
SUREVUE URINE HCG
K010522 · JHI Visual, Pregnancy Hcg,... · Toxicology
Jul 2001 159d
SUREVUE SERUM/URINE HCG, MODEL 1,30,50,100 TEST KIT
K010593 · JHI Visual, Pregnancy Hcg,... · Chemistry
Apr 2001 36d
SAS STREP A TEST
K993456 · GTY Antigens, All Groups,... · Microbiology
Mar 2000 146d
SAS ADENO TEST
K990630 · GOD Antigens, Cf (including... · Microbiology
Aug 1999 174d
SAS ROTA TEST
K990842 · LIQ Enzyme Linked... · Microbiology
Aug 1999 147d
MODIFICATION OF SAS SERUM/URINE HCG
K990684 · JHI Visual, Pregnancy Hcg,... · Chemistry
May 1999 68d
SAS ONE-STEP PREGNANCY
K990741 · JHI Visual, Pregnancy Hcg,... · Chemistry
May 1999 63d
SAS HCG-CHECK
K991193 · LCX Kit, Test, Pregnancy,... · Chemistry
May 1999 26d
SAS HCG SERUM CONTROLS
K990720 · JJX Single (specified)... · Chemistry
Mar 1999 14d
SAS HCG URINE CONTROLS
K990755 · JJX Single (specified)... · Chemistry
Mar 1999 11d
SIGNAL PREGNANCY TEST KIT
K974021 · LCX Kit, Test, Pregnancy,... · Chemistry
Dec 1997 58d
CHOICE ACCU-TEST PREGNANCY TEST KIT
K974154 · LCX Kit, Test, Pregnancy,... · Chemistry
Dec 1997 45d
SAS ONE-STEP PREGNANCY
K964995 · JHI Visual, Pregnancy Hcg,... · Chemistry
Jan 1997 36d
SAS SICKLE CELL TEST
K960947 · GHM Test, Sickle Cell · Hematology
Jul 1996 115d
SAS SALMONELLA O FACTOR 20 ANTISERUM
K961948 · GRM Antisera, All Groups,... · Microbiology
Jun 1996 29d

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