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

Supplies, Blood-Bank

21 CFR 864.9050 / Hematology
FDA source (opens on fda.gov)

KSS is the FDA product code for Supplies, Blood-Bank, a class I device type, regulated under 21 CFR 864.9050. As of , FDA records hold 6 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KSS
Device name
Supplies, Blood-Bank
Regulation
21 CFR 864.9050
Device class
Class I
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
6
Ingested recalls
0

Clearances, product code KSS

By decision year
6 clearances under product code KSS with a decision year between 1976 and 1988, 1980 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KSS by decision year
YearClearances
19761
19803
19811
19881

Applicants with the most clearances

Product code KSS
Applicants holding the most 510(k) clearances under product code KSS
ApplicantClearances
Pre-Dent System3
American Dade1
Dade, Baxter Travenol Diagnostics, Inc.1
U.S. Mfg. & Management, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 39 companies shown, in name order