IDI-STREP B ASSAY


Device Classification Name

nucleic acid amplification assay system, group b streptococcus, direct specimen test

510(k) Number K022504
Device Name IDI-STREP B ASSAY
Original Applicant
INFECTIO DIAGNOSTIC, INC.
p.o. box 103
baldwin, 
MD 
21013

Original Contact judi smith
Regulation Number 866.3740
Classification Product Code
NJR  
Date Received 07/29/2002
Decision Date 11/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No