510(k) K071101

Device: TRU RSV
Applicant: MERIDIAN BIOSCIENCE, INC.
510(k) number: K071101
Product code: GOG
Decision: Substantially Equivalent (SESE)
Decision date: 2007-10-18
Date received: 2007-04-19
Regulation: 866.3405
Classification name: Antisera, Cf, Poliovirus 1-3
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: SUSAN ROLIH
Address: 3471 River Hills Dr. Cincinnati OH US 45244 45244

FDA Registration Numbers#

1524213

Source Documents#

510(k) summary PDF

Primary DI, Brand, Company table
Primary DI	Brand	Company	Published
00840733101847	TRU RSV	MERIDIAN BIOSCIENCE, INC.	2020-12-09
00840733101977	FLU/RSV Positive Control	MERIDIAN BIOSCIENCE, INC.	2020-11-17

Other 510(k) Records For Product Code GOG #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K021172	RSV OIA	Thermo Biostar, Inc.	2002-09-13
K853278	POLIO TYPE I CF ANTIGEN, & TYPE II, III	Hillcrest Biologicals	1985-11-07

Legacy Summary#

summary

FDA Review#

Decision Summary