510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812365Substantially Equivalent

Para 1 Sendai Hemagglutinin

Dutchland Laboratories, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812365 is the FDA 510(k) clearance record for PARA 1 SENDAI HEMAGGLUTININ, a class I device, cleared for Dutchland Laboratories, Inc. on under FDA product code GQR (Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4). FDA records list 75 510(k) clearances for Dutchland Laboratories, Inc., from to . As of , FDA records show no recalls naming K812365.

Clearance record

Decision date
Received
(20 days to decision)
Product code
GQR Antigens, Ha (Including Ha Control), Parainfluenza Virus 1-4
Regulation
21 CFR 866.3400
Device class
Class I
Review panel
Microbiology
Applicant
Dutchland Laboratories, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GQR

Trailing 12 months

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

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