Accuprobe Campylobacter Culture Confirmation

FDA 510(k) K894712 · Gen-Probe, Inc.

Substantially Equivalent

510(k) numberK894712

Submission

Device name
Accuprobe Campylobacter Culture Confirmation
Applicant
Gen-Probe, Inc.
San Diego, CA, US
Received
July 26, 1989
Decision date
November 14, 1989
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
K873670Snap Campylobactor Diagnostic KitLQO · Traditional Molecular Biosystems, Inc.06/08/1988SE
K875101Virogen CMV Antibody TestLQO · Traditional Wampole Laboratories03/01/1988SE
K863270Gene-Trak Campylobacter AssayLQO · Traditional Integrated Genetics08/31/1987SE

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Questions and answers

When was Accuprobe Campylobacter Culture Confirmation cleared by the FDA?

Accuprobe Campylobacter Culture Confirmation (K894712) received a 510(k) decision of Substantially Equivalent on November 14, 1989, 111 days after the submission was received.

What is the product code of K894712?

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