510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K880549Substantially Equivalent

Diacyte Fixative Solution

Cytocorp, Inc., Cleveland OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K880549 is the FDA 510(k) clearance record for DIACYTE FIXATIVE SOLUTION, a class I device, cleared for Cytocorp, Inc. on under FDA product code LDY (Fixative, Formalin-Containing). FDA records list one 510(k) clearance for Cytocorp, Inc. As of , FDA records show no recalls naming K880549.

Clearance record

Decision date
Received
(52 days to decision)
Product code
LDY Fixative, Formalin-Containing
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Cytocorp, Inc. 601 Rockwell Ave., Cleveland OH
Third party review
No

Clearances, product code LDY

Trailing 12 months

FDA records hold no clearances under product code LDY in the trailing twelve months.

FDA records show no clearances under product code LDY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LDY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260