Cleared Traditional

K792014 - LANCER L-INA BUFFER, POLYMER, WASH SOLU
(FDA 510(k) Clearance)

K792014 · Sherwood Medical Industries · Immunology device

Nov 1979

Decision

39d

Days

Class 1

Risk

K792014 is an FDA 510(k) clearance for the LANCER L-INA BUFFER, POLYMER, WASH SOLU. This device is classified as a Nephelometer (Class I - General Controls, product code JZW).

Submitted by Sherwood Medical Industries (Mchenry, US). The FDA issued a Cleared decision on November 13, 1979, 39 days after receiving the submission on October 5, 1979.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 866.4540.

Submission Details

510(k) Number	K792014 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 05, 1979
Decision Date	November 13, 1979
Days to Decision	39 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—