Cleared Traditional

NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER

K863438 · Nova Biomedical Corp. · Chemistry

Sep 1986

Decision

24d

Days

Class 1

Risk

About This 510(k) Submission

K863438 is an FDA 510(k) clearance for the NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER, a Electrode, Ion Selective (non-specified) (Class I — General Controls, product code JJP), submitted by Nova Biomedical Corp. (Waltham, US). The FDA issued a Cleared decision on September 29, 1986, 24 days after receiving the submission on September 5, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.2050.

Submission Details

510(k) Number	K863438 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 05, 1986
Decision Date	September 29, 1986
Days to Decision	24 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—