510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K945584Substantially Equivalent

Nova 16 Analyzer

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

K945584 is the FDA 510(k) clearance record for NOVA 16 ANALYZER, a class I device, cleared for Nova Biomedical Corp. on under FDA product code JJC (Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use). FDA records list 129 510(k) clearances for Nova Biomedical Corp., from to . As of , FDA records show no recalls naming K945584.

Clearance record

Decision date
Received
(86 days to decision)
Product code
JJC Analyzer, Chemistry (Sequential Multiple, Continuous Flow) Clinical Use
Regulation
21 CFR 862.2150
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Nova Biomedical Corp. 200 Prospect St., Walham MA
510(k) summary
Statement
Third party review
No

Clearances, product code JJC

Trailing 12 months

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

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