510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K875227Substantially Equivalent

Sterile Empty Vials

Allertech, Inc., Littleton CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K875227 is the FDA 510(k) clearance record for STERILE EMPTY VIALS, cleared for Allertech, Inc. on under FDA product code LDH. FDA records list one 510(k) clearance for Allertech, Inc. As of , FDA records show no recalls naming K875227.

Clearance record

Decision date
Received
(73 days to decision)
Product code
LDH
Review panel
Unknown
Applicant
Allertech, Inc. 7800 S. Elati, Littleton CO
Third party review
No

Clearances, product code LDH

Trailing 12 months

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

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