Lyfo-Kwik Omi Kit

FDA 510(k) K851978 · Micro-Bio-Logics

Substantially Equivalent

510(k) numberK851978

Submission

Device name
Lyfo-Kwik Omi Kit
Applicant
Micro-Bio-Logics
St. Cloud, MN, US
Received
May 7, 1985
Decision date
June 4, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JSS – Kit, Identification, Enterobacteriaceae
Device class
Class I (low risk)
Regulation
21 CFR 866.2660
Specialty
Microbiology

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K081309E.Coli/P. Aeruginosa Pna FishJSS · Traditional Advandx, Inc.12/19/2008SE
K926002Alamar Bacterial Identification Test PanelJSS · Traditional Alamar Biosciences Laboratory, Inc.09/23/1993SE
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More from Becton Dickinson Microbiology Systems

510(k)DeviceDecision
K870731Lyfo Kwik(Tm) Rus KitJXA · Traditional 06/17/1987SE
K861312Lyfo-Kwik (TM) Coagulase PlasmaJTL · Traditional 04/18/1986SE
K861022Kwik Stik(Tm) Lyfo(Tm) Disk MicroorganismsJTR · Traditional 04/04/1986SE
K855172Kwi (TM) G-Co/TwoJSK · Traditional 02/20/1986SE
K855198Indi Kwik (TM) Co/Two KitJTR · Traditional 01/14/1986SE
K852998Neisseria - Kwik PlusJSX · Traditional 07/23/1985SE
K844014Ono/Co-Two (TM) SystemsJTY · Traditional 10/31/1984SE
K842129Lyfo-Disk MicroorganismsJTR · Traditional 07/03/1984SE

Questions and answers

When was Lyfo-Kwik Omi Kit cleared by the FDA?

Lyfo-Kwik Omi Kit (K851978) received a 510(k) decision of Substantially Equivalent on June 4, 1985, 28 days after the submission was received.

What is the product code of K851978?

The FDA product code is JSS – Kit, Identification, Enterobacteriaceae, a Class I (low risk) device regulated under 21 CFR 866.2660.