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
KQPClass II

Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase

21 CFR 862.1315 / Clinical Chemistry
FDA source (opens on fda.gov)

KQP is the FDA product code for Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase, a class II device type, regulated under 21 CFR 862.1315. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
KQP
Device name
Fluorescent Proc. (Qual.), Galactose-1-Phosphate Uridyl Transferase
Regulation
21 CFR 862.1315
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
7
Ingested recalls
1

Clearances, product code KQP

By decision year
7 clearances under product code KQP with a decision year between 1990 and 2011, 1999 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code KQP by decision year
YearClearances
19901
19971
19992
20101
20112

Applicants with the most clearances

Product code KQP
Applicants holding the most 510(k) clearances under product code KQP
ApplicantClearances
Astoria-Pacific, Inc.3
Bio-Rad2
Alpkem Corp.1
Revvity Health Sciences, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code