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FDA 510(k)

SLIDEX MENINGITE-KIT 5

K-Number: K910210 · 1991-08-12

ApplicantVitek Systems, Inc.
Decision Date1991-08-12
Product CodeGTJ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SLIDEX MENINGITE-KIT 5 is the device name listed in this FDA 510(k) record. The listed applicant is Vitek Systems, Inc.. It received FDA 510(k) clearance on 1991-08-12 under 510(k) number K910210. The device is classified under product code GTJ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLIDEX MENINGITE-KIT 5?

SLIDEX MENINGITE-KIT 5 is a medical device that received FDA 510(k) clearance on 1991-08-12. The listed applicant is Vitek Systems, Inc.. The 510(k) number is K910210.

When did SLIDEX MENINGITE-KIT 5 receive FDA 510(k) clearance?

SLIDEX MENINGITE-KIT 5 received FDA 510(k) clearance on 1991-08-12, under 510(k) number K910210.

Who is the listed applicant for SLIDEX MENINGITE-KIT 5?

The FDA 510(k) record lists Vitek Systems, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SLIDEX MENINGITE-KIT 5?

The FDA product code for SLIDEX MENINGITE-KIT 5 is GTJ.

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Related Devices (Code: GTJ)

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K952791DIRECTIGEN MENINGITIS COMBO TESTBd Becton Dickinson Vacutainer Systems PreanalyticK915330DIRECTIGEN MENINGITIS COMBO TEST KITBd Becton Dickinson Vacutainer Systems PreanalyticK885004BACTIGEN(R) N. MENINGITIDISArmkel, LLCK870089IMMUNOSCAN(TM) DIRECT NEISSERIA MENINGITIDIS KITMicroscan Div. Baxter Healthcare Corp.K854851WELLCOGEN N. MENINGITIDIS B/E. COLI K1 ZL24Wellcome DiagnosticsK854852WELLCOGEN BACTERIAL ANTIGEN KITWellcome Diagnostics

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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