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

Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.

21 CFR 862.3300 / Clinical Toxicology
FDA source (opens on fda.gov)

DPG is the FDA product code for Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep., a class II device type, regulated under 21 CFR 862.3300. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DPG
Device name
Radioimmunoassay, Digitoxin (125-I), Rabbit Antibody, Coated Tube Sep.
Regulation
21 CFR 862.3300
Device class
Class II
Review panel
Clinical Toxicology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
3
Ingested recalls
0

Clearances, product code DPG

By decision year
3 clearances under product code DPG with a decision year between 1978 and 1993, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DPG by decision year
YearClearances
19781
19811
19931

Applicants with the most clearances

Product code DPG
Applicants holding the most 510(k) clearances under product code DPG
ApplicantClearances
Siemens Healthcare Diagnostics Inc.1
Miles Laboratories, Inc.1
Pb Diagnostic Systems, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

No registered establishment in MDM’s records lists product code DPG.