UNI-GOLD CRYPTOSPORIDIUM


Device Classification Name

cryptosporidium spp.

510(k) Number K121565
Device Name UNI-GOLD CRYPTOSPORIDIUM
Applicant
TRINITY BIOTECH
5919 farnsworth ct.
carlsbad, 
CA 
92008

Applicant Contact lupe kagan
Correspondent
TRINITY BIOTECH
5919 farnsworth ct.
carlsbad, 
CA 
92008

Correspodent Contact lupe kagan
Regulation Number 866.3220
Classification Product Code
MHJ  
Date Received 05/29/2012
Decision Date 02/08/2013
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No