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

Microscope, Fluorescence/U.V.

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

IBK is the FDA product code for Microscope, Fluorescence/U.V., a class I device type, regulated under 21 CFR 864.3600. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
IBK
Device name
Microscope, Fluorescence/U.V.
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
1
Ingested recalls
0

Clearances, product code IBK

By decision year
1 clearance under product code IBK with a decision year between 1977 and 1977, 1977 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IBK by decision year
YearClearances
19771

Applicants with the most clearances

Product code IBK
Applicants holding the most 510(k) clearances under product code IBK
ApplicantClearances
Bausch & Lomb Incorporated1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 28 companies shown, in name order