Cleared Traditional

K931361 - IL TEST PHOSPHORUS (FDA 510(k) Clearance)

May 1993
Decision
55d
Days
Class 1
Risk

K931361 is an FDA 510(k) clearance for the IL TEST PHOSPHORUS. This device is classified as a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I - General Controls, product code CEO).

Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on May 11, 1993, 55 days after receiving the submission on March 17, 1993.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1580.

Submission Details

510(k) Number K931361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1993
Decision Date May 11, 1993
Days to Decision 55 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEO — Phosphomolybdate (colorimetric), Inorganic Phosphorus
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.1580