ELECTROLYTES (NA+, K+, CL-), PRODUCT NO’S 114-01, 114-02, 114-03


Device Classification Name

electrode, ion-specific, chloride

510(k) Number K991870
Device Name ELECTROLYTES (NA+, K+, CL-), PRODUCT NO’S 114-01, 114-02, 114-03
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 862.1170
Classification Product Code
CGZ  
Subsequent Product Codes
CEM   JGS  
Date Received 06/01/1999
Decision Date 07/30/1999
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