510(k) K781108

Device: MICROCULT-GC CULTURE TEST
Applicant: MILES LABORATORIES, INC.
510(k) number: K781108
Product code: JSX
Decision: Substantially Equivalent (SESE)
Decision date: 1978-08-31
Date received: 1978-06-30
Regulation: 866.2660
Classification name: Kit, Identification, Neisseria Gonorrhoeae
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 1
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: 803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

3003750284
1924669
3026312356
2032682
3016837106
2029372

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JSX #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K960759	GONOPOX TEST KIT	Medtex Laboratories, Inc.	1996-09-18
K923566	NIZYME TEST KIT	Remel Co.	1992-11-02
K913456	VISI-NEISSERIA	Kev Connecticut Diagnostics, Inc.	1991-10-11
K880511	XACT NEISSERIA	Austin Biological Laboratories	1988-08-25
K881501	MODIFIED IDS RAPID NH SYSTEM	Innovative Diagnostic Systems, Inc.	1988-05-18
K870117	NEISSERIA/BRANHAMELLA DIFFERENTIAL TEST	Pro-Lab, Inc.	1987-03-20
K853544	QUAD FERM +	Analytical Products, Inc.	1985-09-05
K852998	NEISSERIA - KWIK PLUS	Micro-Bio-Logics	1985-07-23
K852582	GONI-KIT	Culture Kits, Inc.	1985-07-12
K833307	PHADEBACK G.C. POSITIVE CONTROLS	Pharmacia, Inc.	1983-12-27
K833180	GONOCHEK-II	E-Y Laboratories, Inc.	1983-11-14
K830364	NEISSERIA IDENTIFICATION DISCS	Oxoid U.S.A., Inc.	1983-03-08
K812048	IDS RAPIDS NH SYSTEMS	Carr-Scarborough Microbiologicals, Inc.	1981-08-18
K811412	NEISSERIA-KWIK	Windsor Laboratories, Inc.	1981-06-16
K782013	GONO-CELL	Abbott Laboratories	1979-04-23

Legacy Summary#

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