510(k) K021172

Device: RSV OIA
Applicant: THERMO BIOSTAR, INC.
510(k) number: K021172
Product code: GOG
Decision: Substantially Equivalent (SESE)
Decision date: 2002-09-13
Date received: 2002-04-12
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: KOHN G ADAMS
Address: 6655 Lookout Rd. Boulder CO US 80301 80301

FDA Registration Numbers#

1524213

Source Documents#

Other 510(k) Records For Product Code GOG #

510(k), Device, Applicant table
510(k)	Device	Applicant	Decision date
K071101	TRU RSV	Meridian Bioscience, Inc.	2007-10-18
K853278	POLIO TYPE I CF ANTIGEN, & TYPE II, III	Hillcrest Biologicals	1985-11-07

Legacy Summary#

summary

FDA Review#

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