AVL 9180 ELECTROLYTE ANALYZER— 510(k) K961458

Clearance details

Applicant

Avl Scientific Corp.

Product code

Code JFP

Device class

Class 2

Regulation

21 CFR 862.1145

Advisory panel

Clinical Chemistry

Date received

1996-04-15

Decision date

1996-06-12

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Roswell, GA, US

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Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K961458.