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

Kit, Serological, Negative Control

21 CFR 862.1660 / Clinical Chemistry
FDA source (opens on fda.gov)

MJY is the FDA product code for Kit, Serological, Negative Control, a class I device type, regulated under 21 CFR 862.1660. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
MJY
Device name
Kit, Serological, Negative Control
Regulation
21 CFR 862.1660
Device class
Class I
Review panel
Clinical Chemistry
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
1
Ingested recalls
0

Clearances, product code MJY

By decision year
1 clearance under product code MJY with a decision year between 1996 and 1996, 1996 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code MJY by decision year
YearClearances
19961

Applicants with the most clearances

Product code MJY
Applicants holding the most 510(k) clearances under product code MJY
ApplicantClearances
Pyramid Biological Corp.1

Companies listing this code with FDA

Companies whose registered establishments list this code