510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K850097Substantially Equivalent

Laser-Lyse

Hematology Marketing Assoc., Concord CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K850097 is the FDA 510(k) clearance record for LASER-LYSE, a class I device, cleared for Hematology Marketing Assoc. on under FDA product code GGK (Products, Red-Cell Lysing Products). FDA records list 14 510(k) clearances for Hematology Marketing Assoc., from to . As of , FDA records show no recalls naming K850097.

Clearance record

Decision date
Received
(77 days to decision)
Product code
GGK Products, Red-Cell Lysing Products
Regulation
21 CFR 864.8540
Device class
Class I
Review panel
Hematology
Applicant
Hematology Marketing Assoc. P.O. Box 6756, Concord CA
Third party review
No

Clearances, product code GGK

Trailing 12 months

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

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