510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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IBJClass I

Light, Microscope

21 CFR 864.3600 / Pathology
FDA source (opens on fda.gov)

IBJ is the FDA product code for Light, Microscope, a class I device type, regulated under 21 CFR 864.3600. As of , FDA records hold 9 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
IBJ
Device name
Light, Microscope
Regulation
21 CFR 864.3600
Device class
Class I
Review panel
Pathology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
9
Ingested recalls
2

Clearances, product code IBJ

By decision year
9 clearances under product code IBJ with a decision year between 1981 and 1988, 1988 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code IBJ by decision year
YearClearances
19811
19822
19831
19851
19861
19883

Applicants with the most clearances

Product code IBJ
Applicants holding the most 510(k) clearances under product code IBJ
ApplicantClearances
Portable Medical Laboratories, Inc.3
Amarel Precision Instruments, Inc.1
Intl. Remote Imaging Systems1
Iris Remote Imaging Systems1
P.A. Research Corp.1
Scientific Imaging, Inc.1
Warner-Lambert Co.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 51 companies shown, in name order