510(k) K904083

Device: RUBEOLA IGM ELISA TEST
Applicant: GULL LABORATORIES, INC.
510(k) number: K904083
Product code: LJB
Decision: Substantially Equivalent (SESE)
Decision date: 1991-01-03
Date received: 1990-09-05
Regulation: 866.3520
Classification name: Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 1
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Contact: FRED W RACHFORD
Address: 1011 E. 4800 S. Salt Lake City UT US 84117 84117

FDA Registration Numbers#

3002800697
3005542422
9610240
3007361513
3008191245
1318354
9615056
8020790
3003268355
2242436
3007208259
2133982
2245285
1641328
3032705
2090110
3007118747
2915274

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code LJB #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K974552	DIAMEDIX IS-MEASLES IGG TEST SYSTEM	Diamedix Corp.	1998-01-28
K971620	QUANTA LITE RUBEOLA (MEASLES) IGG	Inova Diagnostics, Inc.	1997-07-22
K922330	BARTELS RUBEOLA IGG EIA	Baxter Diagnostics, Inc.	1992-09-02
K922335	BARTELS RUBEOLA IGM EIA	Baxter Diagnostics, Inc.	1992-09-02
K910290	VIRATEST-DIA(TM) MEASLES (RUBEOLA)	Virus Reference Laboratory, Inc.	1992-03-18
K903961	MEASLES IGG MICROASSAY	Diamedix Corp.	1990-12-28
K904854	RUBEOLA IGG ELISA TEST	Gull Laboratories, Inc.	1990-12-04
K891990	RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600	Clinical Sciences, Inc.	1989-06-15
K873925	VIRGO(TM) MEASLES IGG ELISA	Electro-Nucleonics Laboratories, Inc.	1988-02-24
K821762	MEASELISA TEST KIT	M.A. Bioproducts	1982-07-30

Legacy Summary#

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