Cleared Traditional

CELL LIFTER

K871559 · Corning Costar Corp. · Microbiology
May 1987
Decision
23d
Days
Class 1
Risk

About This 510(k) Submission

K871559 is an FDA 510(k) clearance for the CELL LIFTER, a Device, General Purpose, Microbiology, Diagnostic (Class I — General Controls, product code LIB), submitted by Corning Costar Corp. (Kennebunk, US). The FDA issued a Cleared decision on May 15, 1987, 23 days after receiving the submission on April 22, 1987. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number K871559 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1987
Decision Date May 15, 1987
Days to Decision 23 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary

Device Classification

Product Code LIB — Device, General Purpose, Microbiology, Diagnostic
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.2660

Similar Devices — LIB Device, General Purpose, Microbiology, Diagnostic

All 42
OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV)
K023677 · Osmetech · Jan 2003
SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB
K920416 · Behring Diagnostics, Inc. · Apr 1992
GULL ELISAWARE
K912558 · Gull Laboratories, Inc. · Sep 1991
CORNING EASY WASH ELISA PLATES
K872273 · Corning Medical & Scientific · Jul 1987
NORMAL SALINE STERILE
K864249 · Mds Laboratories, Inc. · Mar 1987
CORNING ELISA PLATES
K863789 · Corning Medical & Scientific · Oct 1986