Quad Ferm +

FDA 510(k) K853544 · Analytical Products, Inc.

Substantially Equivalent

510(k) numberK853544

Submission

Device name
Quad Ferm +
Applicant
Analytical Products, Inc.
Plainview, NY, US
Received
August 26, 1985
Decision date
September 5, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JSX – Kit, Identification, Neisseria Gonorrhoeae
Device class
Class I (low risk)
Regulation
21 CFR 866.2660
Specialty
Microbiology

Other 510(k)s with product code JSX

510(k)DeviceApplicantDecision
K960759Gonopox Test KitJSX · Traditional Medtex Laboratories, Inc.09/18/1996SE
K923566Nizyme Test KitJSX · Traditional Remel Co.11/02/1992SE
K913456Visi-NeisseriaJSX · Traditional Kev Connecticut Diagnostics, Inc.10/11/1991SE
K880511Xact NeisseriaJSX · Traditional Austin Biological Laboratories08/25/1988SE
K881501Modified Ids Rapid NH SystemJSX · Traditional Innovative Diagnostic Systems, Inc.05/18/1988SE
K870117Neisseria/Branhamella Differential TestJSX · Traditional Pro-Lab, Inc.03/20/1987SE
K852998Neisseria - Kwik PlusJSX · Traditional Micro-Bio-Logics07/23/1985SE
K852582Goni-KitJSX · Traditional Culture Kits, Inc.07/12/1985SE
K833307Phadeback G.C. Positive ControlsJSX · Traditional Pharmacia, Inc.12/27/1983SE
K833180Gonochek-IiJSX · Traditional E-Y Laboratories, Inc.11/14/1983SE

More from E-Y Laboratories, Inc.

510(k)DeviceDecision
K924814Api 20E/UNISCEPT 20EJSS · Traditional 03/11/1993SE
K923684Api Uniscept Mic/Type 2 and 3 and Micro MicJWY · Traditional 12/03/1992SE
K922926Api Uniscept Kb/Type 2 and 3JWY · Traditional 10/13/1992SE
K901559Modification to Api Uniscept 20GPLQL · Traditional 09/10/1990SE
K901390Dmac Indole ReagentJTO · Traditional 04/16/1990SE
K895796Api Uniscept KBJWY · Traditional 11/13/1989SE
K884510Modification Micro-MicJWY · Traditional 11/22/1988SE
K884509Modification Mic/Api Uniscept(R)JWY · Traditional 11/22/1988SE
K880598Modifications to Api Uniscept (R) KBJWY · Traditional 03/23/1988SE
K874466Api Uniscept(R) Micro-Mic(R) System/Uniscept MicJWY · Traditional 12/09/1987SE

Questions and answers

When was Quad Ferm + cleared by the FDA?

Quad Ferm + (K853544) received a 510(k) decision of Substantially Equivalent on September 5, 1985, 10 days after the submission was received.

What is the product code of K853544?

The FDA product code is JSX – Kit, Identification, Neisseria Gonorrhoeae, a Class I (low risk) device regulated under 21 CFR 866.2660.