Trichomonas Direct Enzyme Immunoassay

FDA 510(k) K874259 · California Integrated Diagnostics, Inc.

Substantially Equivalent

510(k) numberK874259

Submission

Device name
Trichomonas Direct Enzyme Immunoassay
Applicant
California Integrated Diagnostics, Inc.
Berkeley, CA, US
Received
October 20, 1987
Decision date
December 7, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JWZ – Kit, Screening, Trichomonas
Device class
Class I (low risk)
Regulation
21 CFR 866.2660
Specialty
Microbiology

Other 510(k)s with product code JWZ

510(k)DeviceApplicantDecision
K033864Genzyme Osom Trichomonas Rapid TestJWZ · Traditional Genzyme Corp.04/02/2004SE
K020595Xenostrip-Tv Trichomonas Cassette Test, Model C1383.01JWZ · Traditional Xenotope Diagnostics, Inc.02/20/2003SE
K020226Xenostrip-Tv Trichomonas Diagnostic Test Kit; Catalog Numbers S1383.01, S1383.02 &…JWZ · Traditional Hellen Professional Services08/22/2002SE
K894246Meriview TM TrichomonasJWZ · Traditional Meridian Diagnostics, Inc.08/15/1989SE
K892802Super DuoJWZ · Traditional Mercia Diagnostics , Ltd.06/13/1989SE
K892263Merifluor(Tm) -TrichomonasJWZ · Traditional Meridian Diagnostics, Inc.05/24/1989SE
K875138Trichomate(R) SuperJWZ · Traditional Mercia Diagnostics , Ltd.05/13/1988SE
K871279Modified Trichomonas Direct Specimen Test KitJWZ · Traditional California Integrated Diagnostics, Inc.04/08/1987SE
K852665Syncor Trich Direct Immunofluorescence AssayJWZ · Traditional Syncor Intl. Corp.08/13/1985SE
K830497Pem-TJWZ · Traditional Hedeco04/05/1983SE

More from Hedeco

510(k)DeviceDecision
K904095Herpes Simplex Virus Tissue Culture Conf. TypingGQL · Traditional 02/01/1991SE
K871279Modified Trichomonas Direct Specimen Test KitJWZ · Traditional 04/08/1987SE
K871278Modified Chlamydia Direct Specimen Test KitLJP · Traditional 04/08/1987SE

Questions and answers

When was Trichomonas Direct Enzyme Immunoassay cleared by the FDA?

Trichomonas Direct Enzyme Immunoassay (K874259) received a 510(k) decision of Substantially Equivalent on December 7, 1987, 48 days after the submission was received.

What is the product code of K874259?

The FDA product code is JWZ – Kit, Screening, Trichomonas, a Class I (low risk) device regulated under 21 CFR 866.2660.