510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K163490Substantially Equivalent

StatStrip Xpress 2 Glucose Hospital Meter System

Nova Biomedical Corporation, Walham MA / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163490 is the FDA 510(k) clearance record for StatStrip Xpress 2 Glucose Hospital Meter System, a class II device, cleared for Nova Biomedical Corporation on under FDA product code PZI (Prescription Use Blood Glucose Meter For Near-Patient Testing). FDA's definition for product code PZI reads: "Intended for use in near-patient testing settings for in vitro diagnostic, multiple-patient use for the quantitative determination of glucose throughout all hospital and all professional healthcare settings for use in determining...". FDA records list 129 510(k) clearances for Nova Biomedical Corporation, from to . As of , FDA records show no recalls naming K163490.

Clearance record

Decision date
Received
(25 days to decision)
Product code
PZI Prescription Use Blood Glucose Meter For Near-Patient Testing
Regulation
21 CFR 862.1345
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Nova Biomedical Corporation 200 Prospect St., Walham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PZI

Trailing 12 months
1 clearance under product code PZI in the twelve months to October 2026, June 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code PZI, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20261
July 20260
August 20260
September 20260
October 20260