510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
MTCClass II

Indicator, Chemical, Enzymatic, Sterilization Process

21 CFR 880.2800 / General Hospital
FDA source (opens on fda.gov)

MTC is the FDA product code for Indicator, Chemical, Enzymatic, Sterilization Process, a class II device type, regulated under 21 CFR 880.2800. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
MTC
Device name
Indicator, Chemical, Enzymatic, Sterilization Process
Regulation
21 CFR 880.2800
Device class
Class II
Review panel
General Hospital
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
2
Ingested recalls
0

Clearances, product code MTC

By decision year
2 clearances under product code MTC with a decision year between 1997 and 2021, 1997 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MTC by decision year
YearClearances
19971
20211

Applicants with the most clearances

Product code MTC
Applicants holding the most 510(k) clearances under product code MTC
ApplicantClearances
North American Science Assoc., Inc.1
True Indicating LLC1

Companies listing this code with FDA

Companies whose registered establishments list this code