Ei-Candida Enzyme Immunoassay EI1001

FDA 510(k) K843286 · Immuno-Mycologics, Inc.

Substantially Equivalent

510(k) numberK843286

Submission

Device name
Ei-Candida Enzyme Immunoassay EI1001
Applicant
Immuno-Mycologics, Inc.
Mchenry, IL, US
Received
August 21, 1984
Decision date
October 1, 1984
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LRF – Candida Spp., Direct Antigen, Id
Device class
Class II (moderate risk)
Regulation
21 CFR 866.3165
Specialty
Microbiology

Other 510(k)s with product code LRF

510(k)DeviceApplicantDecision
K883118On the Spot CandidasureLRF · Traditional Medi-Tech, Inc.09/30/1988SE
K863499Candidate(R) SuperLRF · Traditional Mercia Diagnostics , Ltd.03/19/1987SE

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Questions and answers

When was Ei-Candida Enzyme Immunoassay EI1001 cleared by the FDA?

Ei-Candida Enzyme Immunoassay EI1001 (K843286) received a 510(k) decision of Substantially Equivalent on October 1, 1984, 41 days after the submission was received.

What is the product code of K843286?

The FDA product code is LRF – Candida Spp., Direct Antigen, Id, a Class II (moderate risk) device regulated under 21 CFR 866.3165.