ACID HEMOGLOBIN KIT


Device Classification Name

system, analysis, electrophoretic hemoglobin

510(k) Number K992199
Device Name ACID HEMOGLOBIN KIT
Applicant
HELENA LABORATORIES
1530 lindbergh dr.
p.o. box 752
beaumont, 
TX 
77704

Applicant Contact pat franks
Correspondent
HELENA LABORATORIES
1530 lindbergh dr.
p.o. box 752
beaumont, 
TX 
77704

Correspodent Contact pat franks
Regulation Number 864.7440
Classification Product Code
JBD  
Date Received 06/30/1999
Decision Date 09/21/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No