Cleared Traditional

K874190 - CELL COUNTING GRID GRATICULE
(FDA 510(k) Clearance)

Jan 1988
Decision
83d
Days
Class 1
Risk

K874190 is an FDA 510(k) clearance for the CELL COUNTING GRID GRATICULE. This device is classified as a Light, Microscope (Class I - General Controls, product code IBJ).

Submitted by Portable Medical Laboratories, Inc. (Solana Beach, US). The FDA issued a Cleared decision on January 5, 1988, 83 days after receiving the submission on October 14, 1987.

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

Submission Details

510(k) Number K874190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 14, 1987
Decision Date January 05, 1988
Days to Decision 83 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary

Device Classification

Product Code IBJ — Light, Microscope
Device Class Class I - General Controls
CFR Regulation 21 CFR 864.3600

Similar Devices — IBJ Light, Microscope

All 8
VIDEO ANALYZER 4000
K874750 · Scientific Imaging, Inc. · Apr 1988
THE PURPLE IRIS(TM) CYTOPATHOLOGY WORKSTATION
K874207 · Intl. Remote Imaging Systems · Jan 1988
MCARTHUR MICROSCOPE, STANDARD METAL VERSION
K864049 · Portable Medical Laboratories, Inc. · Oct 1986
MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC.
K854735 · Portable Medical Laboratories, Inc. · Dec 1985
PATHOLOGY INSTRUMENTATION & ACCESSORIES
K823040 · Iris Remote Imaging Systems · Jan 1983
2XC MICROSCOPE
K822207 · Amarel Precision Instruments, Inc. · Aug 1982