RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE


Device Classification Name

culture media, antifungal, susceptibility test

510(k) Number K072827
Device Name RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE
Applicant
REMEL, INC.
12076 santa fe dr.
lenexa, 
KS 
66215

Applicant Contact andre hsiung
Correspondent
REMEL, INC.
12076 santa fe dr.
lenexa, 
KS 
66215

Correspodent Contact andre hsiung
Regulation Number 866.1700
Classification Product Code
MJE  
Date Received 10/03/2007
Decision Date 11/26/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No