Virogen CMV Antibody Test

FDA 510(k) K875101 · Wampole Laboratories

Substantially Equivalent

510(k) numberK875101

Submission

Device name
Virogen CMV Antibody Test
Applicant
Wampole Laboratories
Cranbury, NJ, US
Received
December 10, 1987
Decision date
March 1, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LQO – Dna-Reagents, Campylobacter Spp.
Device class
Class I (low risk)
Regulation
21 CFR 866.3110
Specialty
Microbiology

Other 510(k)s with product code LQO

510(k)DeviceApplicantDecision
K894712Accuprobe Campylobacter Culture ConfirmationLQO · Traditional Gen-Probe, Inc.11/14/1989SE
K873670Snap Campylobactor Diagnostic KitLQO · Traditional Molecular Biosystems, Inc.06/08/1988SE
K863270Gene-Trak Campylobacter AssayLQO · Traditional Integrated Genetics08/31/1987SE

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K882896One-Step HCGDHA · Traditional 10/31/1988SE
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K875161Mat (TM) Microalbumin TestDCF · Traditional 02/17/1988SE
K791309Ucg-LyphotestJHJ · Traditional 07/30/1979SE
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K781794Beta-TecJHI · Traditional 12/29/1978SE
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Questions and answers

When was Virogen CMV Antibody Test cleared by the FDA?

Virogen CMV Antibody Test (K875101) received a 510(k) decision of Substantially Equivalent on March 1, 1988, 82 days after the submission was received.

What is the product code of K875101?

The FDA product code is LQO – Dna-Reagents, Campylobacter Spp., a Class I (low risk) device regulated under 21 CFR 866.3110.