Quadra-Titer I.D.

FDA 510(k) K860208 · Microtech Medical Systems, Inc.

Substantially Equivalent

510(k) numberK860208

Submission

Device name
Quadra-Titer I.D.
Applicant
Microtech Medical Systems, Inc.
Aurora, CO, US
Received
January 22, 1986
Decision date
March 3, 1986
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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K081433Ek/P. Aeruginosa Pna FishJSS · Traditional Advandx, Inc.03/26/2009SE
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

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K935485Fas Fastidious Mic PanelJWY · Traditional 02/16/1995SE
K901598Fastidious Mic PanelJWY · Traditional 11/08/1990SE
K896332Supplement to Anaerobic Mic PanelJWY · Traditional 02/05/1990SE
K884831Anaerobic Mic PanelJWY · Traditional 03/27/1989SE
K863847Mic - Concept(Tm) RX-2JWY · Traditional 12/18/1986SE
K861774Quadra-Titer (TM) I.D. (Modification)JSS · Traditional 05/20/1986SE
K852613Mic-Concept SystemLTW · Traditional 09/20/1985SE
K853745Mic-Concept ViewboxLIB · Traditional 09/19/1985SE
K850725Quadra Titer Micro PlatesLIB · Traditional 04/30/1985SE
K851020Mic-Concept InoculatorJTC · Traditional 03/29/1985SE

Questions and answers

When was Quadra-Titer I.D. cleared by the FDA?

Quadra-Titer I.D. (K860208) received a 510(k) decision of Substantially Equivalent on March 3, 1986, 40 days after the submission was received.

What is the product code of K860208?

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