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
KSYClass I

Boxes, View, Blood Grouping

21 CFR 864.9185 / Hematology
FDA source (opens on fda.gov)

KSY is the FDA product code for Boxes, View, Blood Grouping, a class I device type, regulated under 21 CFR 864.9185. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and no recalls.

Classification record

Product code
KSY
Device name
Boxes, View, Blood Grouping
Regulation
21 CFR 864.9185
Device class
Class I
Review panel
Hematology
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 KSY

By decision year
1 clearance under product code KSY with a decision year between 1979 and 1979, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code KSY by decision year
YearClearances
19791

Applicants with the most clearances

Product code KSY
Applicants holding the most 510(k) clearances under product code KSY
ApplicantClearances
Tekpro1

Companies listing this code with FDA

Companies whose registered establishments list this code