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
LDYClass I

Fixative, Formalin-Containing

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

LDY is the FDA product code for Fixative, Formalin-Containing, a class I device type, regulated under 21 CFR 864.4010. As of , FDA records hold one 510(k) clearance under this code, the most recent dated , and 7 recalls.

Classification record

Product code
LDY
Device name
Fixative, Formalin-Containing
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
1
Ingested recalls
7

Clearances, product code LDY

By decision year
1 clearance under product code LDY with a decision year between 1988 and 1988, 1988 the highest year at 1.
Show the numbers
510(k) clearances under FDA product code LDY by decision year
YearClearances
19881

Applicants with the most clearances

Product code LDY
Applicants holding the most 510(k) clearances under product code LDY
ApplicantClearances
Cytocorp, Inc.1

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 22 companies shown, in name order