510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K914847Substantially Equivalent

Cd8 Monoclonal Antibodies

Gen Trak, Inc., Plymouth Meeting PA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K914847 is the FDA 510(k) clearance record for CD8 MONOCLONAL ANTIBODIES, a class II device, cleared for Gen Trak, Inc. on under FDA product code LIZ (Assay, T Lymphocyte Surface Marker). FDA records list 5 510(k) clearances for Gen Trak, Inc., from to . As of , FDA records show no recalls naming K914847.

Clearance record

Decision date
Received
(235 days to decision)
Product code
LIZ Assay, T Lymphocyte Surface Marker
Regulation
21 CFR 864.5220
Device class
Class II
Review panel
Hematology
Applicant
Gen Trak, Inc. 5100 Campus Dr., Plymouth Meeting PA
510(k) summary
Statement
Third party review
No

Clearances, product code LIZ

Trailing 12 months

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

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