Product code DEX— Immunology

ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HU

Classification name: Alpha-1-B-Glycoprotein, Antigen, Antiserum, Control
Device class: Class 1
Regulation: 21 CFR 866.5420
Advisory panel: Immunology
Total cleared: 5
First cleared: 1976-07-20
Most recent: 1982-12-30

Market context for product code DEX

FDA has cleared 5 devices under product code DEX between 1976 and 1982, filed by 5 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19821 clearance
19801 clearance
19791 clearance
19781 clearance
19761 clearance

Top applicants under product code DEX

Recent clearances under product code DEX

K823765 — ANTI SERA TO HUMAN OROSCOMUCOIDKent Laboratories, Inc.·1982-12-30
K801909 — LSA 290 ASSAY REAGENTS/NEPHELOMETRICJ.T. Baker Chemical Co.·1980-09-26
K791341 — HUMAN ALPHA, ACID GLYCOPROTEINBeckman Instruments, Inc.·1979-08-16
K781023 — ALPHA-1-ACID GLYCOPROTEIN SERUM, ANTI-HUIcl Scientific·1978-08-14
K760143 — SERUM, ALPHA-1-GLYCOPROTEIN ANTI-HUMANOxford Laboratories, Inc.·1976-07-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.