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

Formaldehyde (Formalin, Formol)

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

IGG is the FDA product code for Formaldehyde (Formalin, Formol), a class I device type, regulated under 21 CFR 864.4010. As of , FDA records hold 7 510(k) clearances under this code, the most recent dated , and one recall.

Classification record

Product code
IGG
Device name
Formaldehyde (Formalin, Formol)
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
7
Ingested recalls
1

Clearances, product code IGG

By decision year
7 clearances under product code IGG with a decision year between 1977 and 1988, 1980 the highest year at 3.
Show the numbers
510(k) clearances under FDA product code IGG by decision year
YearClearances
19771
19803
19811
19861
19881

Applicants with the most clearances

Product code IGG
Applicants holding the most 510(k) clearances under product code IGG
ApplicantClearances
Meridian Diagnostics, Inc.3
Anatech, Ltd.1
Central Labs. Assoc. MD Pathologists1
Richard-Allan Medical Ind., Inc.1
Surgipath Medical Industries, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 16 companies shown, in name order