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

Formalin-Saline

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

IGC is the FDA product code for Formalin-Saline, 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
IGC
Device name
Formalin-Saline
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 IGC

By decision year
2 clearances under product code IGC with a decision year between 1996 and 1996, 1996 the highest year at 2.
Show the numbers
510(k) clearances under FDA product code IGC by decision year
YearClearances
19962

Applicants with the most clearances

Product code IGC
Applicants holding the most 510(k) clearances under product code IGC
ApplicantClearances
Incstar Corp.2

Companies listing this code with FDA

Companies whose registered establishments list this code