AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)


Device Classification Name

saccharogenic, amylase

510(k) Number K023396
Device Name AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)
Original Applicant
POINTE SCIENTIFIC, INC.
1025 john a. papalas dr.
lincoln park, 
MI 
48146

Original Contact ron jamison
Regulation Number 862.1070
Classification Product Code
CIJ  
Date Received 10/09/2002
Decision Date 12/23/2002
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