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

Antigen, Antiserum, Control, Antithrombin Iii

21 CFR 864.7060 / Hematology
FDA source (opens on fda.gov)

DDQ is the FDA product code for Antigen, Antiserum, Control, Antithrombin Iii, a class II device type, regulated under 21 CFR 864.7060. As of , FDA records hold 4 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DDQ
Device name
Antigen, Antiserum, Control, Antithrombin Iii
Regulation
21 CFR 864.7060
Device class
Class II
Review panel
Hematology
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
Yes
Ingested clearances
4
Ingested recalls
0

Clearances, product code DDQ

By decision year
4 clearances under product code DDQ with a decision year between 1978 and 1997, 1978 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code DDQ by decision year
YearClearances
19781
19931
19941
19971

Applicants with the most clearances

Product code DDQ
Applicants holding the most 510(k) clearances under product code DDQ
ApplicantClearances
Baxter Diagnostics, Inc.1
Crestat Diagnostics, Inc.1
Ria Diagnostics1
Trace Scientific, Ltd.1

Companies listing this code with FDA

Companies whose registered establishments list this code