510(k) K810835

Device: RUBAZYME - M
Applicant: ABBOTT LABORATORIES
510(k) number: K810835
Product code: GOK
Decision: Substantially Equivalent (SESE)
Decision date: 1981-05-05
Date received: 1981-03-25
Regulation: 866.3510
Classification name: Antisera, Hai (including Hai Control), Rubella
Medical specialty: Microbiology
Review panel: Immunology
Device class: 2
Clearance type: Traditional
Third party reviewed: No

Applicant Contact#

Address: One Abbott Park Rd. Abbott Park IL US 60064 60064

FDA Registration Numbers#

1181055

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code GOK #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K832228	RUBASCAN LATEX CARD TEST	Bd Becton Dickinson Vacutainer Systems Preanalytic	1983-09-29
K792635	ANTIBODY TO RUBELLA VIRUS	Electro-Nucleonics Laboratories, Inc.	1980-03-19
K792133	RUBELISA TEST KIT	Microbiological Assoc.	1980-01-11
K790122	RUBANON	Organon, Inc.	1979-02-15
K781638	RUBINDEX*DIRECT SYSTEM	Ortho Diagnostics, Inc.	1978-12-20
K781392	CYTOMEGILISH TEST KIT	Microbiological Assoc.	1978-10-24
K780010	GOAT ANTI-RUBELLA ANTISERA	Northeast Biomedical Labs., Inc.	1978-01-20
K780063	RUBENOSTICON	Organon, Inc.	1978-01-20
K771956	HUMAN O BUFFER	Flow Laboratories, Inc.	1977-10-28
K771957	RUBELLA HEMAGGLUTINATION REAGENT KIT	Flow Laboratories, Inc.	1977-10-28

Legacy Summary#

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