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

Microscope, Phase Contrast

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

IBM is the FDA product code for Microscope, Phase Contrast, 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 one recall.

Classification record

Product code
IBM
Device name
Microscope, Phase Contrast
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
1

Clearances, product code IBM

By decision year
1 clearance under product code IBM with a decision year between 1989 and 1989, 1989 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IBM by decision year
YearClearances
19891

Applicants with the most clearances

Product code IBM
Applicants holding the most 510(k) clearances under product code IBM
ApplicantClearances
Technalysis, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 13 companies shown, in name order