510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163260Substantially Equivalent

SeptiCyte LAB

Immunexpress, Inc, Seattle WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163260 is the FDA 510(k) clearance record for SeptiCyte LAB, a class II device, cleared for Immunexpress, Inc. on under FDA product code PRE (Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers). FDA's definition for product code PRE reads: "A quantitative gene expression assay using reverse transcription polymerase chain reaction to quantify the relative expression levels of host response genes isolated from whole blood". FDA records list 3 510(k) clearances for Immunexpress, Inc., from to . As of , FDA records show no recalls naming K163260.

Clearance record

Decision date
Received
(88 days to decision)
Product code
PRE Rt-Qpcr Assay For Mrna Transcript Immune Biomarkers
Regulation
21 CFR 866.3215
Device class
Class II
Review panel
Microbiology
Applicant
Immunexpress, Inc. 425 Pontius Ave. N, Seattle WA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PRE

Trailing 12 months

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

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