Cleared Traditional

K801362 - ALBUMIN NEPHELOMETRIC ASSAY (FDA 510(k) Clearance)

K801362 · J.T. Baker Chemical Co. · Chemistry device

Jul 1980

Decision

42d

Days

Class 1

Risk

K801362 is an FDA 510(k) clearance for the ALBUMIN NEPHELOMETRIC ASSAY. This device is classified as a Nephelometer, For Clinical Use (Class I - General Controls, product code JQX).

Submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on July 21, 1980, 42 days after receiving the submission on June 9, 1980.

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

Submission Details

510(k) Number	K801362 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 09, 1980
Decision Date	July 21, 1980
Days to Decision	42 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—