510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981427Substantially Equivalent

Stat Profile M Analyzer

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

K981427 is the FDA 510(k) clearance record for STAT PROFILE M ANALYZER, a class II device, cleared for Nova Biomedical Corp. on under FDA product code GKF (Instrument, Hematocrit, Automated). FDA records list 129 510(k) clearances for Nova Biomedical Corp., from to . As of , FDA records show one recall naming K981427.

Clearance record

Decision date
Received
(26 days to decision)
Product code
GKF Instrument, Hematocrit, Automated
Regulation
21 CFR 864.5600
Device class
Class II
Review panel
Hematology
Applicant
Nova Biomedical Corp. 200 Prospect St., Walham MA
510(k) summary
Statement
Third party review
No

Clearances, product code GKF

Trailing 12 months

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

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