Cleared Traditional

K760838 - LACTO-PHENOL COTTON BLUE MOUNTING FL.
(FDA 510(k) Clearance)

K760838 · I M, Inc. · Immunology device

Nov 1976

Decision

34d

Days

Class 1

Risk

K760838 is an FDA 510(k) clearance for the LACTO-PHENOL COTTON BLUE MOUNTING FL.. This device is classified as a Mounting Media (Class I - General Controls, product code LEB).

Submitted by I M, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 16, 1976, 34 days after receiving the submission on October 13, 1976.

This device falls under the Immunology FDA review panel. Regulated under 21 CFR 864.4010.

Submission Details

510(k) Number	K760838 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	October 13, 1976
Decision Date	November 16, 1976
Days to Decision	34 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	—