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

Microtome, Rotary

21 CFR 864.3010 / Pathology
FDA source (opens on fda.gov)

IDO is the FDA product code for Microtome, Rotary, a class I device type, regulated under 21 CFR 864.3010. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
IDO
Device name
Microtome, Rotary
Regulation
21 CFR 864.3010
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
5
Ingested recalls
1

Clearances, product code IDO

By decision year
5 clearances under product code IDO with a decision year between 1981 and 1987, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code IDO by decision year
YearClearances
19812
19841
19861
19871

Applicants with the most clearances

Product code IDO
Applicants holding the most 510(k) clearances under product code IDO
ApplicantClearances
Lkb Instruments, Inc.3
Miles Laboratories, Inc.1
Surgipath Medical Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 27 companies shown, in name order