Mumps Complement-Fixation (C.F.) Antigen

FDA 510(k) K905306 · Virion (U.S.), Inc.

Substantially Equivalent

510(k) numberK905306

Submission

Device name
Mumps Complement-Fixation (C.F.) Antigen
Applicant
Virion (U.S.), Inc.
Morristown, NJ, US
Received
November 28, 1990
Decision date
June 17, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GRC – Antigen, Cf (Including Cf Control), Mumps Virus
Device class
Class I (low risk)
Regulation
21 CFR 866.3380
Specialty
Microbiology

Other 510(k)s with product code GRC

510(k)DeviceApplicantDecision
K832873Mumps Complement Fixation & HemaggluGRC · Traditional Hazleton Dutchland, Inc.12/27/1983SE
K802933Mumps S & V Antigens & ControlsGRC · Traditional Orion Diagnostica, Inc.12/31/1980SE

More from Orion Diagnostica, Inc.

510(k)DeviceDecision
K933251Epstein-Barr Virus Combi Test, Ebv Combi TestMCD · Traditional 06/13/1994SE
K921618Coxsackie Virus B1-B6 CF AntigensGNG · Traditional 06/29/1992SE
K905385P.I.V. Complement-Fixation (C.F.) AntigenGQS · Traditional 03/21/1991SE
K864981Toxoplasma GondiiGMN · Traditional 10/30/1987SE

Questions and answers

When was Mumps Complement-Fixation (C.F.) Antigen cleared by the FDA?

Mumps Complement-Fixation (C.F.) Antigen (K905306) received a 510(k) decision of Substantially Equivalent on June 17, 1991, 201 days after the submission was received.

What is the product code of K905306?

The FDA product code is GRC – Antigen, Cf (Including Cf Control), Mumps Virus, a Class I (low risk) device regulated under 21 CFR 866.3380.