510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
IGMClass I

Solution, Carnoy'S

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

IGM is the FDA product code for Solution, Carnoy'S, a class I device type, regulated under 21 CFR 864.4010. As of , FDA records hold 3 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
IGM
Device name
Solution, Carnoy'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
3
Ingested recalls
0

Clearances, product code IGM

By decision year
3 clearances under product code IGM with a decision year between 1979 and 1984, 1979 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code IGM by decision year
YearClearances
19791
19821
19841

Applicants with the most clearances

Product code IGM
Applicants holding the most 510(k) clearances under product code IGM
ApplicantClearances
E K Ind., Inc.1
Marion Laboratories, Inc.1
Volu Sol Medical Industries1

Companies listing this code with FDA

Companies whose registered establishments list this code