510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K180186Substantially Equivalent

Stat Profile Prime Plus Analyzer System

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

K180186 is the FDA 510(k) clearance record for Stat Profile Prime Plus Analyzer System, a class II device, cleared for Nova Biomedical Corporation on under FDA product code GGZ (Oxyhemoglobin). FDA records list 129 510(k) clearances for Nova Biomedical Corporation, from to . As of , FDA records show no recalls naming K180186.

Clearance record

Decision date
Received
(212 days to decision)
Product code
GGZ Oxyhemoglobin
Regulation
21 CFR 864.7500
Device class
Class II
Review panel
Hematology
Applicant
Nova Biomedical Corporation 200 Prospect St., Walham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code GGZ

Trailing 12 months

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

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