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
K833665Substantially Equivalent

Hematology Wright's-Giemsa Satin Pack

J.S. Medical Assoc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K833665 is the FDA 510(k) clearance record for HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK, a class I device, cleared for J.S. Medical Assoc. on under FDA product code HYF (Giemsa Stain). FDA records list 18 510(k) clearances for J.S. Medical Assoc., from to . As of , FDA records show no recalls naming K833665.

Clearance record

Decision date
Received
(38 days to decision)
Product code
HYF Giemsa Stain
Regulation
21 CFR 864.1850
Device class
Class I
Review panel
Hematology
Applicant
J.S. Medical Assoc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code HYF

Trailing 12 months

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

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