510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K801507Substantially Equivalent

Antigen Control Cells

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

K801507 is the FDA 510(k) clearance record for ANTIGEN CONTROL CELLS, a class II device, cleared for Ortho Diagnostics, Inc. on under FDA product code GOL (Antigen, Ha (Including Ha Control), Rubella). FDA records list 24 510(k) clearances for Ortho Diagnostics, Inc., from to . As of , FDA records show no recalls naming K801507.

Clearance record

Decision date
Received
(51 days to decision)
Product code
GOL Antigen, Ha (Including Ha Control), Rubella
Regulation
21 CFR 866.3510
Device class
Class II
Review panel
Microbiology
Applicant
Ortho Diagnostics, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GOL

Trailing 12 months

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

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