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
K813513Substantially Equivalent

African Green Monkey Blood in Alservers

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

K813513 is the FDA 510(k) clearance record for AFRICAN GREEN MONKEY BLOOD IN ALSERVERS, a class I device, cleared for Dutchland Laboratories, Inc. on under FDA product code LHW (Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment). FDA records list 75 510(k) clearances for Dutchland Laboratories, Inc., from to . As of , FDA records show no recalls naming K813513.

Clearance record

Decision date
Received
(16 days to decision)
Product code
LHW Erythrocyte Suspension, Multi Species, Serological Reagent And Equipment
Regulation
21 CFR 866.3720
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 LHW

Trailing 12 months

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

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