G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE


Device Classification Name

glucose-6-phosphate dehydrogenase (erythrocytic), screening

510(k) Number K024006
Device Name G6PDH, GLUCOSE-6-PHOSHATE DEHYDROGENASE
Original Applicant
POINTE SCIENTIFIC, INC.
1025 john a. papalas dr.
lincoln park, 
MI 
48146

Original Contact ron jamison
Regulation Number 864.7360
Classification Product Code
JBF  
Date Received 12/04/2002
Decision Date 03/31/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No