510(k) K971620

Device: QUANTA LITE RUBEOLA (MEASLES) IGG
Applicant: INOVA DIAGNOSTICS, INC.
510(k) number: K971620
Product code: LJB
Decision: Substantially Equivalent (SESE)
Decision date: 1997-07-22
Date received: 1997-05-01
Regulation: 866.3520
Classification name: Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 1
Clearance type: Traditional
Statement or summary: Statement
Third party reviewed: No

Applicant Contact#

Contact: BRYS C MYERS
Address: 10451 Roselle St. San Diego CA US 92121 92121

FDA Registration Numbers#

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

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
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
K904083	RUBEOLA IGM ELISA TEST	Gull Laboratories, Inc.	1991-01-03
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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