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
DEXClass I

Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control

21 CFR 866.5420 / Immunology
FDA source (opens on fda.gov)

DEX is the FDA product code for Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.5420. As of , FDA records hold 5 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DEX
Device name
Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control
Regulation
21 CFR 866.5420
Device class
Class I
Review panel
Immunology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
5
Ingested recalls
0

Clearances, product code DEX

By decision year
5 clearances under product code DEX with a decision year between 1976 and 1982, 1976 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DEX by decision year
YearClearances
19761
19781
19791
19801
19821

Applicants with the most clearances

Product code DEX
Applicants holding the most 510(k) clearances under product code DEX
ApplicantClearances
Beckman Instruments, Inc.1
Icl Scientific1
J.T. Baker Chemical Co.1
Kent Laboratories, Inc.1
Oxford Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code