Cleared Traditional

K873932 - THE EXTRACTOR(TM)
(FDA 510(k) Clearance)

Nov 1987
Decision
56d
Days
Class 1
Risk

K873932 is an FDA 510(k) clearance for the THE EXTRACTOR(TM). This device is classified as a Adsorbents, Ion-exchange (Class I - General Controls, product code DKO).

Submitted by Molecular Biosystems, Inc. (San Diego, US). The FDA issued a Cleared decision on November 20, 1987, 56 days after receiving the submission on September 25, 1987.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 862.2230.

Submission Details

510(k) Number K873932 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 1987
Decision Date November 20, 1987
Days to Decision 56 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code DKO — Adsorbents, Ion-exchange
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.2230