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

Complement C5, Antigen, Antiserum, Control

21 CFR 866.5240 / Immunology
FDA source (opens on fda.gov)

DAY is the FDA product code for Complement C5, Antigen, Antiserum, Control, a class II device type, regulated under 21 CFR 866.5240. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
DAY
Device name
Complement C5, Antigen, Antiserum, Control
Regulation
21 CFR 866.5240
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
3
Ingested recalls
0

Clearances, product code DAY

By decision year
3 clearances under product code DAY with a decision year between 1978 and 1995, 1995 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code DAY by decision year
YearClearances
19781
19952

Applicants with the most clearances

Product code DAY
Applicants holding the most 510(k) clearances under product code DAY
ApplicantClearances
Gelman Instrument Co.1
Jay H. Geller1
Kent Laboratories, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code