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

Enzyme Immunoassay, Diphenylhydantoin

21 CFR 862.3350 / Clinical Toxicology
FDA source (opens on fda.gov)

DIP is the FDA product code for Enzyme Immunoassay, Diphenylhydantoin, a class II device type, regulated under 21 CFR 862.3350. As of , FDA records hold 44 510(k) clearances under this code, the most recent dated , and 11 recalls.

Classification record

Product code
DIP
Device name
Enzyme Immunoassay, Diphenylhydantoin
Regulation
21 CFR 862.3350
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
44
Ingested recalls
11

Clearances, product code DIP

By decision year
44 clearances under product code DIP with a decision year between 1977 and 2008, 1986 the highest year at 5.
Show the numbers
510(k) clearances under FDA product code DIP by decision year
YearClearances
19772
19781
19811
19832
19844
19853
19865
19873
19881
19891
19903
19913
19921
19931
19942
19952
19961
19971
20002
20012
20031
20071
20081

Applicants with the most clearances

Product code DIP
Applicants holding the most 510(k) clearances under product code DIP
ApplicantClearances
Abbott Medical4
Syva Co.4
E.I. Dupont de Nemours & Co., Inc.3
Em Diagnostic Systems, Inc.3
Syva Co.3
Instrumentation Laboratory Co.2
Schiapparelli Biosystems, Inc.2
Syva Co.2
Allied Instrumentation Laboratory1
Baxter Diagnostics, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order