ALKALINE PHOPHATASE (ALP), PRODUCT NO’S 118-01, 118-02


Device Classification Name

nitrophenylphosphate, alkaline phosphatase or isoenzymes

510(k) Number K991762
Device Name ALKALINE PHOPHATASE (ALP), PRODUCT NO’S 118-01, 118-02
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 862.1050
Classification Product Code
CJE  
Date Received 05/24/1999
Decision Date 09/02/1999
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