510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K112955Substantially Equivalent

Nova Statstrip Lactate Hospital Meter System

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

K112955 is the FDA 510(k) clearance record for NOVA STATSTRIP LACTATE HOSPITAL METER SYSTEM, a class I device, cleared for Nova Biomedical Corporation on under FDA product code KHP (Acid, Lactic, Enzymatic Method). FDA records list 129 510(k) clearances for Nova Biomedical Corporation, from to . As of , FDA records show no recalls naming K112955.

Clearance record

Decision date
Received
(93 days to decision)
Product code
KHP Acid, Lactic, Enzymatic Method
Regulation
21 CFR 862.1450
Device class
Class I
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 KHP

Trailing 12 months

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

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