URIC ACID, MODEL UA112-01


Device Classification Name

acid, uric, uricase (colorimetric)

510(k) Number K991247
Device Name URIC ACID, MODEL UA112-01
Applicant
A.P. TOTAL CARE, INC.
70 hawley ave,
po box 6216
bridgeport, 
CT 

Applicant Contact luis p leon
Correspondent
A.P. TOTAL CARE, INC.
70 hawley ave,
po box 6216
bridgeport, 
CT 

Correspodent Contact luis p leon
Regulation Number 862.1775
Classification Product Code
KNK  
Date Received 04/12/1999
Decision Date 05/25/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No