Chlamydia

FDA 510(k) K843654 · Institute Virion , Ltd.

Substantially Equivalent

510(k) numberK843654

Submission

Device name
Chlamydia
Applicant
Institute Virion , Ltd.
Mchenry, IL, US
Received
September 17, 1984
Decision date
August 8, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GPW – Antigen, Cf, Psittacosis (Chlamydia Group)
Device class
Class I (low risk)
Regulation
21 CFR 866.3120
Specialty
Microbiology

Other 510(k)s with product code GPW

510(k)DeviceApplicantDecision
K872700Yhlamydia CF Antigen and Control AntigenGPW · Traditional Sita, Inc.10/15/1987SE
K844868Chlamydia Group CF AntigenGPW · Traditional Hillcrest Biologicals03/05/1985SE
K811570Antibody to Chlamydia TrachomatisGPW · Traditional Electro-Nucleonics Laboratories, Inc.07/23/1981SE

More from Electro-Nucleonics Laboratories, Inc.

510(k)DeviceDecision
K862814Complement-Fixation Test for Campylobacter JejuniLQP · Traditional 09/30/1986SE
K843676Varicella/Zoster VirusGQW · Traditional 09/26/1985SE
K843673Respiratory Syncytial VirusGQG · Traditional 09/26/1985SE
K843667Parainfluenza 3GQS · Traditional 09/26/1985SE
K843665Parainfluenza 1GQS · Traditional 09/26/1985SE
K843662Measles Virus RubeolaGRJ · Traditional 09/26/1985SE
K843660In Fluenza B VirusGNX · Traditional 09/26/1985SE
K843659Influenza A2 VirusGNX · Traditional 09/26/1985SE
K843658H. Simplex VirusGQN · Traditional 09/26/1985SE
K843657CytomegalovirusGQH · Traditional 09/26/1985SE

Questions and answers

When was Chlamydia cleared by the FDA?

Chlamydia (K843654) received a 510(k) decision of Substantially Equivalent on August 8, 1985, 325 days after the submission was received.

What is the product code of K843654?

The FDA product code is GPW – Antigen, Cf, Psittacosis (Chlamydia Group), a Class I (low risk) device regulated under 21 CFR 866.3120.