SAS Brucella Melitensis Antiserum

FDA 510(k) K952143 · Sa Scientific, Inc.

Substantially Equivalent

510(k) numberK952143

Submission

Device name
SAS Brucella Melitensis Antiserum
Applicant
Sa Scientific, Inc.
San Antonio, TX, US
Received
May 8, 1995
Decision date
July 21, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
GSM – Antisera, Fluorescent, Brucella Spp.
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3085
Specialty
Microbiology

Other 510(k)s with product code GSM

510(k)DeviceApplicantDecision
K952146SAS Brucellas Abortus AntiserumGSM · Traditional Sa Scientific, Inc.07/21/1995SE
K952144SAS Brucella Suis AntiserumGSM · Traditional Sa Scientific, Inc.07/21/1995SE
K952132SAS Brucella Ams AntiserumGSM · Traditional Sa Scientific, Inc.07/21/1995SE

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K080380SAS Influenza a & B TestPSZ · Traditional 07/23/2009SE
K061496SAS Legionella Test, SAS Legionella Dipstick TestMJH · Traditional 06/28/2007SE
K041441SAS Influenza a TestPSZ · Traditional 07/22/2004SE
K041439SAS Influenza B TestPSZ · Traditional 07/22/2004SE
K030628SAS RSV Control KitJJX · Traditional 03/17/2003SE
K022845SAS RSV TestGQG · Traditional 01/29/2003SE
K022683SAS Blood/Serum/Urine/Urine HCGJHI · Traditional 12/16/2002SE
K023270SAS StrepalertGTY · Traditional 10/17/2002SE

Questions and answers

When was SAS Brucella Melitensis Antiserum cleared by the FDA?

SAS Brucella Melitensis Antiserum (K952143) received a 510(k) decision of Substantially Equivalent on July 21, 1995, 74 days after the submission was received.

What is the product code of K952143?

The FDA product code is GSM – Antisera, Fluorescent, Brucella Spp., a Class II (moderate risk) device regulated under 21 CFR 866.3085.