Latex R. Conorii

FDA 510(k) K872129 · Health Research, Inc.

Substantially Equivalent

510(k) numberK872129

Submission

Device name
Latex R. Conorii
Applicant
Health Research, Inc.
Albany, NY, US
Received
June 2, 1987
Decision date
August 19, 1987
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LSQ – Reagent, Rickettsia Serological
Device class
Class I (low risk)
Regulation
21 CFR 866.3500
Specialty
Microbiology

Other 510(k)s with product code LSQ

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K971591Indx Dip-S-Ticks Scrub Typhus Test for the Detection of Igg and Igm Antibodies to…LSQ · Traditional David C. Bishop, Ph.D.03/13/1998SE
K920569Indxtm Dip-S-TickstmLSQ · Traditional Intercare Diagnostics, Inc.02/09/1993SE
K901597Indx Dip S TicksLSQ · Traditional Intercare Diagnostics, Inc.12/21/1990SE

More from Intercare Diagnostics, Inc.

510(k)DeviceDecision
K860557Latex R. TyphiGPM · Traditional 04/21/1986SE
K843794Latex-R RickettsiiGPP · Traditional 01/04/1985SE

Questions and answers

When was Latex R. Conorii cleared by the FDA?

Latex R. Conorii (K872129) received a 510(k) decision of Substantially Equivalent on August 19, 1987, 78 days after the submission was received.

What is the product code of K872129?

The FDA product code is LSQ – Reagent, Rickettsia Serological, a Class I (low risk) device regulated under 21 CFR 866.3500.