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
MYTClass II

Biosensor, Immunoassay, Cpk Or Isoenzymes

21 CFR 862.1215 / Clinical Chemistry
FDA source (opens on fda.gov)

MYT is the FDA product code for Biosensor, Immunoassay, Cpk Or Isoenzymes, a class II device type, regulated under 21 CFR 862.1215. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
MYT
Device name
Biosensor, Immunoassay, Cpk Or Isoenzymes
Regulation
21 CFR 862.1215
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
1

Clearances, product code MYT

By decision year
3 clearances under product code MYT with a decision year between 1999 and 2005, 1999 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MYT by decision year
YearClearances
19991
20041
20051

Applicants with the most clearances

Product code MYT
Applicants holding the most 510(k) clearances under product code MYT
ApplicantClearances
Biocentrex1
I-Stat Corp.1
Quantech, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code