510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K821019Substantially Equivalent

Phosphate Buffered Clycerol Mounting Flu

Microbiological Research Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K821019 is the FDA 510(k) clearance record for PHOSPHATE BUFFERED CLYCEROL MOUNTING FLU, a class I device, cleared for Microbiological Research Corp. on under FDA product code LEB (Mounting Media). FDA records list 14 510(k) clearances for Microbiological Research Corp., from to . As of , FDA records show no recalls naming K821019.

Clearance record

Decision date
Received
(14 days to decision)
Product code
LEB Mounting Media
Regulation
21 CFR 864.4010
Device class
Class I
Review panel
Pathology
Applicant
Microbiological Research Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code LEB

Trailing 12 months

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

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