Cleared Traditional

K780372 - CRE. PHOSPHOKINASE ISOENZYMES, REA. SYS. (FDA 510(k) Clearance)

May 1978
Decision
56d
Days
Risk

K780372 is an FDA 510(k) clearance for the CRE. PHOSPHOKINASE ISOENZYMES, REA. SYS...

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on May 3, 1978, 56 days after receiving the submission on March 8, 1978.

This device falls under the Chemistry FDA review panel.

Submission Details

510(k) Number K780372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1978
Decision Date May 03, 1978
Days to Decision 56 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code
Device Class