510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K822980Substantially Equivalent

Midas 1000 Wright Stain #66010

EMD Millipore Corporation, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K822980 is the FDA 510(k) clearance record for MIDAS 1000 WRIGHT STAIN #66010, a class I device, cleared for Emd Chemicals, Inc. on under FDA product code IAF (Wright'S Stain). FDA records list 94 510(k) clearances for EMD MILLIPORE CORPORATION, from to . As of , FDA records show no recalls naming K822980.

Clearance record

Decision date
Received
(19 days to decision)
Product code
IAF Wright'S Stain
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
Emd Chemicals, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code IAF

Trailing 12 months

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

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