OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K992086
Device Name OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2
Applicant
OLYMPUS AMERICA, INC.
two corporate center dr.
melville, 
NY 
11747 -3157

Applicant Contact laura storms-tyler
Correspondent
OLYMPUS AMERICA, INC.
two corporate center dr.
melville, 
NY 
11747 -3157

Correspodent Contact laura storms-tyler
Regulation Number 862.1150
Classification Product Code
JIX  
Date Received 06/21/1999
Decision Date 08/19/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Toxicology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No