510(k) K991473

Device: SIRSCAN
Applicant: INTELLIGENCE ARTIFICIELLE APPLICATIONS
510(k) number: K991473
Product code: KZK
Decision: Substantially Equivalent (SESE)
Decision date: 1999-11-23
Date received: 1999-04-27
Regulation: 866.2850
Classification name: Reader, Zone, Automated
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: MARC J SCHEINESON
Address: 1301k St., NW Suite 1100 - E. Tower Washington DC US 20005 20005

FDA Registration Numbers#

2433947

Source Documents#

Other 510(k) Records For Product Code KZK #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K944319	BIOMIC MICROBIOLOGY DATA MANAGEMENT SYSTEM	Giles Scientific, Inc.	1994-12-15
K932122	BIOMIC VIDEO PLATE READER	Giles Scientific, Inc.	1994-03-01

Legacy Summary#

summary

FDA Review#

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