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

Fluid, Bouin'S

21 CFR 864.4010 / Pathology
FDA source (opens on fda.gov)

IGN is the FDA product code for Fluid, Bouin'S, a class I device type, regulated under 21 CFR 864.4010. As of , FDA records hold 2 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IGN
Device name
Fluid, Bouin'S
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Submission type
510(k) exempt
Implant
No
Life sustaining or supporting
No
GMP exempt
Yes
Third party review eligible
No
Ingested clearances
2
Ingested recalls
0

Clearances, product code IGN

By decision year
2 clearances under product code IGN with a decision year between 1982 and 1983, 1982 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IGN by decision year
YearClearances
19821
19831

Applicants with the most clearances

Product code IGN
Applicants holding the most 510(k) clearances under product code IGN
ApplicantClearances
Sigma Chemical Co.1
Volu Sol Medical Industries1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 14 companies shown, in name order