SAS Febrile Positive & Negative Control Antiserum

FDA 510(k) K952145 · Sa Scientific, Inc.

Substantially Equivalent

510(k) numberK952145

Submission

Device name
SAS Febrile Positive & Negative Control Antiserum
Applicant
Sa Scientific, Inc.
San Antonio, TX, US
Received
May 8, 1995
Decision date
July 18, 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
GSN – Antiserum, Positive And Negative Febrile Antigen Control Serum
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3085
Specialty
Microbiology

Other 510(k)s with product code GSN

510(k)DeviceApplicantDecision
K885113Ifa* Positive and Negative Antigens ControlGSN · Traditional Investigacion Farmaceutica S.A. DE C.V.08/15/1989SE
K791385Negative Control Serum for CF Ro IdGSN · Traditional Immuno-Mycologics, Inc.08/16/1979SE

More from Immuno-Mycologics, Inc.

510(k)DeviceDecision
K132352SAS Flualert a & B, SAS Influenza a TestGNX · Special 08/22/2013SE
K100227SAS Flualert A&B, SAS Influenza a TestPSZ · Special 02/23/2010SE
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 Febrile Positive & Negative Control Antiserum cleared by the FDA?

SAS Febrile Positive & Negative Control Antiserum (K952145) received a 510(k) decision of Substantially Equivalent on July 18, 1995, 71 days after the submission was received.

What is the product code of K952145?

The FDA product code is GSN – Antiserum, Positive And Negative Febrile Antigen Control Serum, a Class II (moderate risk) device regulated under 21 CFR 866.3085.