IMX HOMOCYSTEINE— 510(k) K980812

Substantially Equivalent

Axis Biochemicals, Asa

FDA 510(k) clearance K980812 for IMX HOMOCYSTEINE, Substantially Equivalent on 1998-10-01. Applicant: Axis Biochemicals, Asa. Device class: 2.

Clearance details

Applicant: Axis Biochemicals, Asa
Product code: Code DFC
Device class: Class 2
Regulation: 21 CFR 866.5600
Advisory panel: Immunology
Date received: 1998-03-03
Decision date: 1998-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Axis Biochemicals, Asa

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K980907 — AXIS HOMOCYSTEINE ENZYME IMMUNOASSAY1998-10-16

Data sourced from openFDA. This site is unofficial and independent of the FDA.