510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K963005Substantially Equivalent

Nova 16 Analyzer (Modification Point of Care Usage)

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

K963005 is the FDA 510(k) clearance record for NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE), a class II device, cleared for Nova Biomedical Corp. on under FDA product code JFL (Ph Rate Measurement, Carbon-Dioxide). FDA records list 129 510(k) clearances for Nova Biomedical Corp., from to . As of , FDA records show no recalls naming K963005.

Clearance record

Decision date
Received
(21 days to decision)
Product code
JFL Ph Rate Measurement, Carbon-Dioxide
Regulation
21 CFR 862.1160
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Nova Biomedical Corp. 200 Prospect St., Walham MA
510(k) summary
Statement
Third party review
No

Clearances, product code JFL

Trailing 12 months

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

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