MICROALBUMIN REAGENT SET AND CALIBRATORS


Device Classification Name

albumin, fitc, antigen, antiserum, control

510(k) Number K023860
Device Name MICROALBUMIN REAGENT SET AND CALIBRATORS
Original Applicant
POINTE SCIENTIFIC, INC.
1025 john a. papalas dr.
lincoln park, 
MI 
48146

Original Contact ron jamison
Regulation Number 866.5040
Classification Product Code
DDZ  
Subsequent Product Code
JIT  
Date Received 11/20/2002
Decision Date 04/28/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No