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FDA 510(k)

SLIDEX STAPH-KIT

K-Number: K923212 · 1992-09-28

ApplicantBiomerieux Vitek, Inc.
Decision Date1992-09-28
Product CodeJWX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SLIDEX STAPH-KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biomerieux Vitek, Inc.. It received FDA 510(k) clearance on 1992-09-28 under 510(k) number K923212. The device is classified under product code JWX. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SLIDEX STAPH-KIT?

SLIDEX STAPH-KIT is a medical device that received FDA 510(k) clearance on 1992-09-28. The listed applicant is Biomerieux Vitek, Inc.. The 510(k) number is K923212.

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

SLIDEX STAPH-KIT received FDA 510(k) clearance on 1992-09-28, under 510(k) number K923212.

Who is the listed applicant for SLIDEX STAPH-KIT?

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

What is the FDA product code for SLIDEX STAPH-KIT?

The FDA product code for SLIDEX STAPH-KIT is JWX.

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Related Devices (Code: JWX)

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K090964BINAXNOX STAPHYLOCOCCUS AUREUS TESTBinax, Inc.K972030STAPHYTECT PLUS/DRYSPOT STAPHYTECT PLUSOxoid , Ltd.K964315REMEL STAPH LATEX KITRemel, L.P.K945538STAPHAUREX PLUS(TM)Murex Diagnostics LimitdK926173STAPH-A-LEX(TM) SYSTEMTrinity Laboratories, Inc.K905617VISI-STAPHConnecticut Diagnostics, Ltd.

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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