Na/K Fluida Pack for Nova 1 Analyzer

by Fisher Scientific Co., LLC 510(k)

Active United States

510(k) K833712

Regulatory status

as of 28 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK833712	Date13 Jan 1984Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not known
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number: K833712
FDA Product Code: JGS

Device Class: Class II
Regulation: 21 CFR Part 862.1665
Advisory Committee: Clinical Chemistry
FDA Decision: SESE Substantially Equivalent

Other devices from Fisher Scientific Co., LLC

Total Bilirubin

Class II
Calibrating Solution for Abl-1 & 2

Class II
Reagent for Coulter Counter Model 5+11

Class I
Total Protein Reagent Cs-724

Class II
Cleaning Solution For Radiometer OSM2

Class II
Diagnostics Po 2 Electrolyte

Class II

See all devices from Fisher Scientific Co., LLC →