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FDA Product Code

FDA Product Code CIL — Clearance Directory

Device Class
Class II
Assigned Panel
Clinical Chemistry
21 CFR Citation
862.1160

510(k) Clearances — 4 records

K-Number Device Name Applicant Decision Date Clearance Type Summary
K922953 SYSTEMATE CALCIUM TEST TECHNICON RA 1000 Em Diagnostic Systems, Inc. 1992-09-09 Traditional PDF ↗
K895880 PANCREATIC A-AMYLASE EPS Boehringer Mannheim Corp. 1989-12-19 Traditional PDF ↗
K833724 ENZYMATIC CO2 American Monitor Corp. 1983-12-29 Traditional PDF ↗
K800111 CO2 CONTENT American Monitor Corp. 1980-02-13 Traditional PDF ↗

Product code CIL · Class II · Clinical Chemistry. Data: openFDA.