510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830164Substantially Equivalent

Densitometric Inhalent Profile Sller

Mast Immunosystems, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830164 is the FDA 510(k) clearance record for DENSITOMETRIC INHALENT PROFILE SLLER, a class II device, cleared for Mast Immunosystems on under FDA product code DGC (Ige, Antigen, Antiserum, Control). FDA records list 13 510(k) clearances for Mast Immunosystems, from to . As of , FDA records show no recalls naming K830164.

Clearance record

Decision date
Received
(42 days to decision)
Product code
DGC Ige, Antigen, Antiserum, Control
Regulation
21 CFR 866.5510
Device class
Class II
Review panel
Immunology
Applicant
Mast Immunosystems 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DGC

Trailing 12 months

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

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