Cleared Traditional

K802158 - POSTASSIUM BUFFER SOL. & WASH SOLUTION (FDA 510(k) Clearance)

K802158 · Panmed, Inc. · Chemistry device

Oct 1980

Decision

32d

Days

Class 2

Risk

K802158 is an FDA 510(k) clearance for the POSTASSIUM BUFFER SOL. & WASH SOLUTION. This device is classified as a Electrode, Ion Specific, Potassium (Class II - Special Controls, product code CEM).

Submitted by Panmed, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 10, 1980, 32 days after receiving the submission on September 8, 1980.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1600.

Submission Details

510(k) Number	K802158 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 08, 1980
Decision Date	October 10, 1980
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—