510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K802404Substantially Equivalent

Ortho Bovine Albumin Solution 30% Prote

Ortho Diagnostics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K802404 is the FDA 510(k) clearance record for ORTHO BOVINE ALBUMIN SOLUTION 30% PROTE, a class II device, cleared for Ortho Diagnostics, Inc. on under FDA product code DCF (Albumin, Antigen, Antiserum, Control). FDA records list 24 510(k) clearances for Ortho Diagnostics, Inc., from to . As of , FDA records show no recalls naming K802404.

Clearance record

Decision date
Received
(17 days to decision)
Product code
DCF Albumin, Antigen, Antiserum, Control
Regulation
21 CFR 866.5040
Device class
Class II
Review panel
Immunology
Applicant
Ortho Diagnostics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DCF

Trailing 12 months

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

FDA records show no clearances under product code DCF in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code DCF, 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