DOCUMENT THYROID CAL*VER


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K992034
Device Name DOCUMENT THYROID CAL*VER
Applicant
CASCO-NERL DIAGNOSTICS CORPORATION (MAINE)
500 riverside industrial pkwy.
portland, 
ME 
04103

Applicant Contact karen hickey
Correspondent
CASCO-NERL DIAGNOSTICS CORPORATION (MAINE)
500 riverside industrial pkwy.
portland, 
ME 
04103

Correspodent Contact karen hickey
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 06/16/1999
Decision Date 07/23/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No