Cleared Traditional

K792045 - BIOVATION NEPHELOMETER
(FDA 510(k) Clearance)

K792045 · Biovation, Inc. · Chemistry

Oct 1979

Decision

18d

Days

Class 1

Risk

K792045 is an FDA 510(k) clearance for the BIOVATION NEPHELOMETER. This device is classified as a Nephelometer, For Clinical Use (Class I — General Controls, product code JQX).

Submitted by Biovation, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 30, 1979, 18 days after receiving the submission on October 12, 1979.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2700.

Submission Details

510(k) Number	K792045 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 12, 1979
Decision Date	October 30, 1979
Days to Decision	18 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—