Mycoplasma SPP Serological Reagents

FDA 510(k) K852933 · Microbix Biosystems, Inc.

Substantially Equivalent

510(k) numberK852933

Submission

Device name
Mycoplasma SPP Serological Reagents
Applicant
Microbix Biosystems, Inc.
Canada, CA
Received
July 9, 1985
Decision date
August 1, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GSB – Antigens, Cf, All, Mycoplasma Spp.
Device class
Class I (low risk)
Regulation
21 CFR 866.3375
Specialty
Microbiology

Other 510(k)s with product code GSB

510(k)DeviceApplicantDecision
K843664Mycoplasma PneumoniaeGSB · Traditional Institute Virion , Ltd.10/25/1984SE
K834338Mycoplasma Pneumoniae CF AntigenGSB · Traditional Hillcrest Biologicals02/27/1984SE
K832132Sera-Tek Mycoplasma Antibody TestGSB · Traditional Miles Laboratories, Inc.09/20/1983SE
K802934Mycoplasma Pneumoniae Antigen & ControlGSB · Traditional Orion Diagnostica, Inc.12/31/1980SE

More from Orion Diagnostica, Inc.

510(k)DeviceDecision
K894262Rubella Antigen and Control AntigenGON · Traditional 10/16/1989SE
K894261Toxoplasma Gondii-Cf Antigen and Control AntigenGMN · Traditional 10/16/1989SE
K852932Measles-Complement Fix Antigen & Negative CLTGRF · Traditional 11/12/1985SE
K852931Herpes Hominus I-Comple Fix Antigen & Negative CLTGQO · Traditional 11/12/1985SE
K852930Varicella-Zoster-Comple Fix Antigen and Neg ControGQX · Traditional 11/12/1985SE
K852929Cmv-Complement Fixation Antigen and Negative ContrGQI · Traditional 11/12/1985SE

Questions and answers

When was Mycoplasma SPP Serological Reagents cleared by the FDA?

Mycoplasma SPP Serological Reagents (K852933) received a 510(k) decision of Substantially Equivalent on August 1, 1985, 23 days after the submission was received.

What is the product code of K852933?

The FDA product code is GSB – Antigens, Cf, All, Mycoplasma Spp., a Class I (low risk) device regulated under 21 CFR 866.3375.