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FDA 510(k)

VISI-STAPH

K-Number: K905617 · 1991-03-29

ApplicantConnecticut Diagnostics, Ltd.
Decision Date1991-03-29
Product CodeJWX
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

VISI-STAPH is the device name listed in this FDA 510(k) record. The listed applicant is Connecticut Diagnostics, Ltd.. It received FDA 510(k) clearance on 1991-03-29 under 510(k) number K905617. 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 VISI-STAPH?

VISI-STAPH is a medical device that received FDA 510(k) clearance on 1991-03-29. The listed applicant is Connecticut Diagnostics, Ltd.. The 510(k) number is K905617.

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

VISI-STAPH received FDA 510(k) clearance on 1991-03-29, under 510(k) number K905617.

Who is the listed applicant for VISI-STAPH?

The FDA 510(k) record lists Connecticut Diagnostics, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VISI-STAPH?

The FDA product code for VISI-STAPH is JWX.

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Other records listing Connecticut Diagnostics, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K822500CDL LYSING REAGENTK822504CDL AUTO-LYSING REAGENTK822501CDL ISOTONIC DILUENTK811222INORGANIC PHOSPHORUS REAGENTSK801897GLUCOSE DIAGNOSTIC REAGENTK801898URIC ACID DIAGNOSTIC REAGENT

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Related Devices (Code: JWX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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.K923212SLIDEX STAPH-KITBiomerieux Vitek, Inc.

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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