510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K210254Substantially Equivalent

MeMed BV

MeMed Diagnostics Ltd, Tirat Carmel, IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K210254 is the FDA 510(k) clearance record for MeMed BV, a class II device, cleared for MeMed Diagnostics, Ltd. on under FDA product code QPS (Immunoassay For Host Biomarkers Of Infection). FDA's definition for product code QPS reads: "A semi-quantitative immunoassay that quantifies the relative levels of host response proteins isolated from serum or similar specimens". FDA records list 3 510(k) clearances for MeMed Diagnostics, Ltd., from to . As of , FDA records show no recalls naming K210254.

Clearance record

Decision date
Received
(215 days to decision)
Product code
QPS Immunoassay For Host Biomarkers Of Infection
Regulation
21 CFR 866.3215
Device class
Class II
Review panel
Microbiology
Applicant
MeMed Diagnostics, Ltd. Nahum Heth 5, Tirat Carmel, IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QPS

Trailing 12 months

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

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