510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013169Substantially Equivalent

Immune Cell Function Assay

Cylex, Inc., Baldwin MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K013169 is the FDA 510(k) clearance record for IMMUNE CELL FUNCTION ASSAY, a class II device, cleared for Cylex, Inc. on under FDA product code NID (Assay, Proliferation, In Vitro, T Lymphocyte). FDA's definition for product code NID reads: "A device measuring the constituents of dividing DNA or other pre-division cellular constituents to classify the ability of T lymphocytes (a type of normal white blood mononuclear cell) to divide or proliferate in response to specific or...". FDA records list 2 510(k) clearances for Cylex, Inc., from to . As of , FDA records show no recalls naming K013169.

Clearance record

Decision date
Received
(193 days to decision)
Product code
NID Assay, Proliferation, In Vitro, T Lymphocyte
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Cylex, Inc. P.O.Box 103, Baldwin MD
510(k) summary
Summary
Third party review
No

Clearances, product code NID

Trailing 12 months

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

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