VISI-STAPH— 510(k) K905617

Substantially Equivalent

Connecticut Diagnostics, Ltd.

FDA 510(k) clearance K905617 for VISI-STAPH, Substantially Equivalent on 1991-03-29. Applicant: Connecticut Diagnostics, Ltd.. Device class: 1.

Clearance details

Applicant: Connecticut Diagnostics, Ltd.
Product code: Code JWX
Device class: Class 1
Regulation: 21 CFR 866.2660
Advisory panel: Microbiology
Date received: 1990-12-14
Decision date: 1991-03-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danielson, CT, US

Download summary PDF View on FDA.gov ↗

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K811222 — INORGANIC PHOSPHORUS REAGENTS1981-05-21
K801897 — GLUCOSE DIAGNOSTIC REAGENT1980-10-10

Data sourced from openFDA. This site is unofficial and independent of the FDA.