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

Alpha-1-Lipoprotein, Antigen, Antiserum, Control

21 CFR 866.5580 / Immunology
FDA source (opens on fda.gov)

DER is the FDA product code for Alpha-1-Lipoprotein, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5580. As of , FDA records hold 17 510(k) clearances under this code, the most recent dated , and 2 recalls.

Classification record

Product code
DER
Device name
Alpha-1-Lipoprotein, Antigen, Antiserum, Control
Regulation
21 CFR 866.5580
Device class
Class II
Review panel
Immunology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
17
Ingested recalls
2

Clearances, product code DER

By decision year
17 clearances under product code DER with a decision year between 1981 and 2001, 1999 the highest year at 4.
Show the numbers
510(k) clearances under FDA product code DER by decision year
YearClearances
19811
19841
19852
19861
19871
19901
19911
19973
19994
20001
20011

Applicants with the most clearances

Product code DER
Applicants holding the most 510(k) clearances under product code DER
ApplicantClearances
Crestat Diagnostics, Inc.3
Photec Diagnostics, Inc.3
Kamiya Biomedical Company, LLC2
Roche Diagnostics GmbH2
Abbott Medical1
Bayer Corp.1
Eucardio Laboratory, Inc.1
Hyland Therapeutic Div., Travenol Laboratories1
Roche Diagnostic Systems, Inc.1
Solomon Park Research Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code