510(k) K040708

Device: STATUS FIRST STREP A
Applicant: PRINCETON BIOMEDITECH CORP.
510(k) number: K040708
Product code: GTY
Decision: Substantially Equivalent (SESE)
Decision date: 2004-11-22
Date received: 2004-03-18
Regulation: 866.3740
Classification name: Antigens, All Groups, Streptococcus Spp.
Medical specialty: Microbiology
Review panel: Microbiology
Device class: 1
Clearance type: Traditional
Statement or summary: Summary
Third party reviewed: No

Applicant Contact#

Contact: JEMO KANG
Address: 4242 U.S. Rt. 1 Monmouth Junction NJ US 08852 08852

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

summary

FDA Review#

Decision Summary