Cell Counting Grid Graticule

FDA 510(k) K874190 · Portable Medical Laboratories, Inc.

Substantially Equivalent

510(k) numberK874190

Submission

Device name
Cell Counting Grid Graticule
Applicant
Portable Medical Laboratories, Inc.
Solana Beach, CA, US
Received
October 14, 1987
Decision date
January 5, 1988
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
IBJ – Light, Microscope
Device class
Class I (low risk)
Regulation
21 CFR 864.3600
Specialty
Pathology

Other 510(k)s with product code IBJ

510(k)DeviceApplicantDecision
K874750Video Analyzer 4000IBJ · Traditional Scientific Imaging, Inc.04/25/1988SE
K874207The Purple Iris(Tm) Cytopathology WorkstationIBJ · Traditional Intl. Remote Imaging Systems01/05/1988SE
K864049Mcarthur Microscope, Standard Metal VersionIBJ · Traditional Portable Medical Laboratories, Inc.10/29/1986SE
K854735Mcarthur Microscope Plastic Version with Acc.IBJ · Traditional Portable Medical Laboratories, Inc.12/10/1985SE
K823040Pathology Instrumentation & AccessoriesIBJ · Traditional Iris Remote Imaging Systems01/14/1983SE
K8222072XC MicroscopeIBJ · Traditional Amarel Precision Instruments, Inc.08/05/1982SE
K821865A O Microscope Video SystemIBJ · Traditional Warner-Lambert Co.07/14/1982SE
K802818Pullen Pocket ScopeIBJ · Traditional P.A. Research Corp.04/17/1981SE

More from P.A. Research Corp.

510(k)DeviceDecision
K882101Hemoglobin Screening DeviceKSL · Traditional 07/01/1988SE
K871671Urinoscopy FunnelGHO · Traditional 05/20/1987SE
K864049Mcarthur Microscope, Standard Metal VersionIBJ · Traditional 10/29/1986SE
K854735Mcarthur Microscope Plastic Version with Acc.IBJ · Traditional 12/10/1985SE
K844476Portable Diagnostic LaboratoryLIB · Traditional 03/13/1985SE
K844475Specimen Collection & Transport SystemFMF · Traditional 02/06/1985SE
K844442Rapid Diagnostic KitLIB · Traditional 02/01/1985SE
K844473Hand-Held Slide ReaderLIB · Traditional 01/04/1985SE

Questions and answers

When was Cell Counting Grid Graticule cleared by the FDA?

Cell Counting Grid Graticule (K874190) received a 510(k) decision of Substantially Equivalent on January 5, 1988, 83 days after the submission was received.

What is the product code of K874190?

The FDA product code is IBJ – Light, Microscope, a Class I (low risk) device regulated under 21 CFR 864.3600.