Cleared Traditional

K770594 - LABORATORY EXPENDABLE PRODUCTS
(FDA 510(k) Clearance)

Jul 1977
Decision
100d
Days
Class 1
Risk

K770594 is an FDA 510(k) clearance for the LABORATORY EXPENDABLE PRODUCTS. This device is classified as a Micro Pipette (Class I - General Controls, product code JRC).

Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 6, 1977, 100 days after receiving the submission on March 28, 1977.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number K770594 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1977
Decision Date July 06, 1977
Days to Decision 100 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary

Device Classification

Product Code JRC — Micro Pipette
Device Class Class I - General Controls
CFR Regulation 21 CFR 862.2050