Cleared Traditional

K801567 - CYBREX THEOPHYLLINE (FDA 510(k) Clearance)

Jul 1980
Decision
13d
Days
Risk

K801567 is an FDA 510(k) clearance for the CYBREX THEOPHYLLINE..

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on July 21, 1980, 13 days after receiving the submission on July 8, 1980.

This device falls under the Toxicology FDA review panel.

Submission Details

510(k) Number K801567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 08, 1980
Decision Date July 21, 1980
Days to Decision 13 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary

Device Classification

Product Code
Device Class