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

Device, Blood Mixing And Blood Weighing

21 CFR 864.9195 / Hematology
FDA source (opens on fda.gov)

KSQ is the FDA product code for Device, Blood Mixing And Blood Weighing, a class I device type, regulated under 21 CFR 864.9195. As of , FDA records hold 8 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
KSQ
Device name
Device, Blood Mixing And Blood Weighing
Regulation
21 CFR 864.9195
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
8
Ingested recalls
0

Clearances, product code KSQ

By decision year
8 clearances under product code KSQ with a decision year between 1976 and 1984, 1980 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KSQ by decision year
YearClearances
19761
19781
19802
19812
19821
19841

Applicants with the most clearances

Product code KSQ
Applicants holding the most 510(k) clearances under product code KSQ
ApplicantClearances
Helmer Labs, Inc.2
Lifeline Instruments, Inc.2
R & D Systems, Inc.1
Royco Instruments1
Separation Science Corp.1
Travenol Laboratories, S.A.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 17 companies shown, in name order