IVD CRYPTO/GIARDIA DFA


Device Classification Name

giardia spp.

510(k) Number K024113
Device Name IVD CRYPTO/GIARDIA DFA
Original Applicant
IVD RESEARCH, INC.
5909 sea lion place, suite d
carlsbad, 
CA 
92008

Original Contact dave lambillotte
Regulation Number 866.3220
Classification Product Code
MHI  
Subsequent Product Code
MHJ  
Date Received 12/13/2002
Decision Date 03/05/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party Yes

Combination Product

No