Cleared Traditional

K822518 - CSM BETA-LACTAMASE DISC
(FDA 510(k) Clearance)

Sep 1982
Decision
29d
Days
Risk

K822518 is an FDA 510(k) clearance for the CSM BETA-LACTAMASE DISC..

Submitted by Carr-Scarborough Microbiologicals, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 21, 1982, 29 days after receiving the submission on August 23, 1982.

This device falls under the Microbiology FDA review panel.

Submission Details

510(k) Number K822518 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 23, 1982
Decision Date September 21, 1982
Days to Decision 29 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code
Device Class