Cleared Traditional

K770652 - FLUORESCENCE ILLUMINATOR ACCESSORY (FDA 510(k) Clearance)

K770652 · Bausch & Lomb, Inc. · Pathology device
Jul 1977
Decision
91d
Days
Class 1
Risk

K770652 is an FDA 510(k) clearance for the FLUORESCENCE ILLUMINATOR ACCESSORY. This device is classified as a Microscope, Fluorescence/u.v. (Class I - General Controls, product code IBK).

Submitted by Bausch & Lomb, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1977, 91 days after receiving the submission on April 6, 1977.

This device falls under the Pathology FDA review panel. Regulated under 21 CFR 864.3600.

Submission Details

510(k) Number K770652 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1977
Decision Date July 06, 1977
Days to Decision 91 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -

Device Classification

Product Code IBK - Microscope, Fluorescence/u.v.
Device Class Class I - General Controls
CFR Regulation 21 CFR 864.3600