510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K812372Substantially Equivalent

Guinea Pig Blood in Alsever's, Cit., Def

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

K812372 is the FDA 510(k) clearance record for GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEF, a class I device, cleared for Dutchland Laboratories, Inc. on under FDA product code LHT (Staphylococcus Aureus Somatic Antigens). FDA records list 75 510(k) clearances for Dutchland Laboratories, Inc., from to . As of , FDA records show no recalls naming K812372.

Clearance record

Decision date
Received
(20 days to decision)
Product code
LHT Staphylococcus Aureus Somatic Antigens
Regulation
21 CFR 866.3700
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 LHT

Trailing 12 months

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

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