Visi-Staph

FDA 510(k) K905617 · Connecticut Diagnostics, Ltd.

Substantially Equivalent

510(k) numberK905617

Submission

Device name
Visi-Staph
Applicant
Connecticut Diagnostics, Ltd.
Danielson, CT, US
Received
December 14, 1990
Decision date
March 29, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JWX – Kit, Screening, Staphylococcus Aureus
Device class
Class I (low risk)
Regulation
21 CFR 866.2660
Specialty
Microbiology

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K964315Remel Staph Latex KitJWX · Traditional Remel, L.P.02/07/1997SE
K945538Staphaurex Plus(Tm)JWX · Traditional Murex Diagnostics Limitd06/01/1995SE
K926173Staph-A-Lex(Tm) SystemJWX · Traditional Trinity Laboratories, Inc.08/10/1993SE
K923212Slidex Staph-KitJWX · Traditional Biomerieux Vitek, Inc.09/28/1992SE
K902259Axiom Total Knee System, Tibial ComponentJWX · Traditional Orthomet, Inc.06/18/1990SN
K874019StaphslideJWX · Traditional Ncs Diagnostics, Inc.10/28/1987SE
K854278Neg Combo Breakpoint Panel Pos ComboJWX · Traditional American Micro Scan03/04/1986SE
K855220V-Trend Kit Staph Latex TestJWX · Traditional Texas Immunology, Inc.03/03/1986SE

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Questions and answers

When was Visi-Staph cleared by the FDA?

Visi-Staph (K905617) received a 510(k) decision of Substantially Equivalent on March 29, 1991, 105 days after the submission was received.

What is the product code of K905617?

The FDA product code is JWX – Kit, Screening, Staphylococcus Aureus, a Class I (low risk) device regulated under 21 CFR 866.2660.