Device Atlas

Pathology Instrumentation & Accessories

Q: What is the product code of K823040?

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

FDA 510(k) K823040 · Iris Remote Imaging Systems

Substantially Equivalent

510(k) numberK823040

Submission

Device name: Pathology Instrumentation & Accessories
Applicant: Iris Remote Imaging Systems
Mchenry, IL, US
Received: October 14, 1982
Decision date: January 14, 1983
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)	Device	Applicant	Decision
K874750	Video Analyzer 4000IBJ · Traditional	Scientific Imaging, Inc.	04/25/1988SE
K874207	The Purple Iris(Tm) Cytopathology WorkstationIBJ · Traditional	Intl. Remote Imaging Systems	01/05/1988SE
K874190	Cell Counting Grid GraticuleIBJ · Traditional	Portable Medical Laboratories, Inc.	01/05/1988SE
K864049	Mcarthur Microscope, Standard Metal VersionIBJ · Traditional	Portable Medical Laboratories, Inc.	10/29/1986SE
K854735	Mcarthur Microscope Plastic Version with Acc.IBJ · Traditional	Portable Medical Laboratories, Inc.	12/10/1985SE
K822207	2XC MicroscopeIBJ · Traditional	Amarel Precision Instruments, Inc.	08/05/1982SE
K821865	A O Microscope Video SystemIBJ · Traditional	Warner-Lambert Co.	07/14/1982SE
K802818	Pullen Pocket ScopeIBJ · Traditional	P.A. Research Corp.	04/17/1981SE

Questions and answers

When was Pathology Instrumentation & Accessories cleared by the FDA?

Pathology Instrumentation & Accessories (K823040) received a 510(k) decision of Substantially Equivalent on January 14, 1983, 92 days after the submission was received.

What is the product code of K823040?

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