Cleared Traditional

K781000 - PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS (FDA 510(k) Clearance)

Dec 1978
Decision
172d
Days
Class 1
Risk

K781000 is an FDA 510(k) clearance for the PHOSPHORUS (INORGANIC) ANALYSIS PRODUCTS. This device is classified as a Phosphomolybdate (colorimetric), Inorganic Phosphorus (Class I - General Controls, product code CEO).

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on December 4, 1978, 172 days after receiving the submission on June 15, 1978.

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

Submission Details

510(k) Number K781000 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1978
Decision Date December 04, 1978
Days to Decision 172 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

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