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
KQGClass II

Instrument, Coagulation

21 CFR 864.5400 / Hematology
FDA source (opens on fda.gov)

KQG is the FDA product code for Instrument, Coagulation, a class II device type, regulated under 21 CFR 864.5400. As of , FDA records hold 14 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KQG
Device name
Instrument, Coagulation
Regulation
21 CFR 864.5400
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
14
Ingested recalls
1

Clearances, product code KQG

By decision year
14 clearances under product code KQG with a decision year between 1977 and 2005, 1999 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code KQG by decision year
YearClearances
19771
19791
19822
19852
19861
19902
19993
20021
20051

Applicants with the most clearances

Product code KQG
Applicants holding the most 510(k) clearances under product code KQG
ApplicantClearances
Med USA2
Pacific Hemostasis2
Volu Sol Medical Industries2
Accriva Diagnostics, Inc.1
Logos Scientific, Inc.1
Medical Laboratory Automation Systems, Inc.1
Ortho Diagnostic Systems, Inc.1
Texas Intl. Laboratories, Inc.1
Thermolyne Corp.1
VitalScientific1

Companies listing this code with FDA

Companies whose registered establishments list this code