MODIFICATION TO IMX HOMOCYSTEINE


Device Classification Name

urinary homocystine (nonquantitative) test system

510(k) Number K992274
Device Name MODIFICATION TO IMX HOMOCYSTEINE
Applicant
AXIS BIOCHEMICALS, ASA
po box 262069
san diego, 
CA 
92196

Applicant Contact ronald g leonardi
Correspondent
AXIS BIOCHEMICALS, ASA
po box 262069
san diego, 
CA 
92196

Correspodent Contact ronald g leonardi
Regulation Number 862.1377
Classification Product Code
LPS  
Date Received 07/06/1999
Decision Date 10/06/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No