Alpha Cryptococcal Antigen Eia

FDA 510(k) K120946 · Immuno-Mycologics, Inc.

Substantially Equivalent

510(k) numberK120946

Submission

Device name
Alpha Cryptococcal Antigen Eia
Applicant
Immuno-Mycologics, Inc.
Norman, OK, US
Received
March 29, 2012
Decision date
December 17, 2012
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MDU – Antigen, Elisa, Cryptococcus
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3165
Specialty
Microbiology

Other 510(k)s with product code MDU

510(k)DeviceApplicantDecision
K904393Premier-Cryptococcal AntigenMDU · Traditional Meridian Diagnostics, Inc.01/25/1991SE

More from Meridian Diagnostics, Inc.

510(k)DeviceDecision
K112422Crag Lateral Flow Assay (Lfa)GMD · Traditional 03/28/2012SE
K102286Crag Lateral Flow Assay (Crag Lfa)GMD · Traditional 07/20/2011SE
K101407Alpha Histoplasma Antigen Eia Model HAG102MIZ · Traditional 07/19/2011SE
K883333Rabbit Plasma Fibrinogen (RPF) SupplementJTL · Traditional 08/25/1988SE
K880029Exo-Antigen Identification System Cat.# EX1001KFH · Traditional 02/24/1988SE
K843286Ei-Candida Enzyme Immunoassay EI1001LRF · Traditional 10/01/1984SE
K831918La-Staph Identification SystemJWX · Traditional 06/08/1983SE
K830837La-Histo Antibody System #Hl 1001GMJ · Traditional 05/05/1983SE
K810510Ya-Crypto Antibody Tube AgglutinationGMD · Traditional 03/20/1981SE
K802427La-Sporo Antibody SystemGMA · Traditional 10/31/1980SE

Questions and answers

When was Alpha Cryptococcal Antigen Eia cleared by the FDA?

Alpha Cryptococcal Antigen Eia (K120946) received a 510(k) decision of Substantially Equivalent on December 17, 2012, 263 days after the submission was received.

What is the product code of K120946?

The FDA product code is MDU – Antigen, Elisa, Cryptococcus, a Class II (moderate risk) device regulated under 21 CFR 866.3165.