AMIZYME-EBV TEST KIT— 510(k) K842530

Substantially Equivalent

Amico Lab, Inc.

FDA 510(k) clearance K842530 for AMIZYME-EBV TEST KIT, Substantially Equivalent on 1985-12-06. Applicant: Amico Lab, Inc.. Device class: 1.

Clearance details

Applicant: Amico Lab, Inc.
Product code: Code GNP
Device class: Class 1
Regulation: 21 CFR 866.3235
Advisory panel: Microbiology
Date received: 1984-06-28
Decision date: 1985-12-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: TN, US

Download summary PDF View on FDA.gov ↗

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More clearances from Amico Lab, Inc.

K842662 — ANTI-EPSTEIN-BARR VIRUS KIT1985-12-12
K842529 — AMIZYME-CMV KIT1985-12-06
K842531 — AMIZYME-HSV TYPES 1 & 2 TEST KITS1985-12-06
K842661 — ANTI-CYTOMEGALOVIRUS KIT1985-12-06
K842663 — ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 21985-12-06

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