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

Protein, Complement, Antigen, Antiserum, Control

21 CFR 866.4100 / Immunology
FDA source (opens on fda.gov)

DHL is the FDA product code for Protein, Complement, Antigen, Antiserum, Control, a class I device type, regulated under 21 CFR 866.4100. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DHL
Device name
Protein, Complement, Antigen, Antiserum, Control
Regulation
21 CFR 866.4100
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
4
Ingested recalls
0

Clearances, product code DHL

By decision year
4 clearances under product code DHL with a decision year between 1977 and 1987, 1981 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DHL by decision year
YearClearances
19771
19812
19871

Applicants with the most clearances

Product code DHL
Applicants holding the most 510(k) clearances under product code DHL
ApplicantClearances
Cedarlake Labs, Ltd.1
Diamedix Corp.1
Kallestad Laboratories, Inc.1
Scripps-Miles, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code