C. Albicans Screen

FDA 510(k) K891476 · Carr-Scarborough Microbiologicals, Inc.

Substantially Equivalent

510(k) numberK891476

Submission

Device name
C. Albicans Screen
Applicant
Carr-Scarborough Microbiologicals, Inc.
Stone Mountain, GA, US
Received
March 16, 1989
Decision date
April 12, 1989
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

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

Other 510(k)s with product code JXC

510(k)DeviceApplicantDecision
K960075Chromagar CandidaJXC · Traditional Hardy Diagnostics08/02/1996SE
K913426Albicans SureJXC · Traditional Jrga Diagnostics04/22/1992SE
K884720Germ Tube SolutionJXC · Traditional Remel Co.06/02/1989SE
K882371Soc Slide Culture SystemJXC · Traditional The Cancer Center AT Wadley Institutes07/18/1988SE
K832406Quantum II Yeast Ident. SystemJXC · Traditional Abbott Laboratories09/26/1983SE

More from Abbott Laboratories

510(k)DeviceDecision
K944554Brain Heart Infusion AgarJSO · Traditional 10/04/1994SE
K941985Mueller Hinton Agar W/OxacillinJTZ · Traditional 08/24/1994SE
K905472Lap DiscsJTO · Traditional 02/27/1991SE
K905666M. Cat. Butyrate DiscJTO · Traditional 02/26/1991SE
K882636Aln DiscsJTO · Traditional 02/16/1989SE
K882630Pro DiscsJTO · Traditional 02/16/1989SE
K863216Neis NzyJTO · Traditional 09/15/1986SE
K860301Rapid Glutamic Acid Decarboxylase (GDC) MicrotubeJTO · Traditional 02/06/1986SE
K860302Pyr DiscsJTO · Traditional 02/05/1986SE
K822930CSM Chromogenic B-Lactamase DiscJTO · Traditional 11/01/1982SE

Questions and answers

When was C. Albicans Screen cleared by the FDA?

C. Albicans Screen (K891476) received a 510(k) decision of Substantially Equivalent on April 12, 1989, 27 days after the submission was received.

What is the product code of K891476?

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