510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K902614Substantially Equivalent

Elvi 828 Digiclot Multiscan

Logos Scientific, Inc., Henderson NV / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K902614 is the FDA 510(k) clearance record for ELVI 828 DIGICLOT MULTISCAN, a class II device, cleared for Logos Scientific, Inc. on under FDA product code KQG (Instrument, Coagulation). FDA records list 9 510(k) clearances for Logos Scientific, Inc., from to . As of , FDA records show no recalls naming K902614.

Clearance record

Decision date
Received
(148 days to decision)
Product code
KQG Instrument, Coagulation
Regulation
21 CFR 864.5400
Device class
Class II
Review panel
Hematology
Applicant
Logos Scientific, Inc. 700 Sunset Rd., Henderson NV
Third party review
No

Clearances, product code KQG

Trailing 12 months

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

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