AMIZYME-CMV KIT— 510(k) K842529

Substantially Equivalent

Amico Lab, Inc.

FDA 510(k) clearance K842529 for AMIZYME-CMV KIT, Substantially Equivalent on 1985-12-06. Applicant: Amico Lab, Inc.. Device class: 2.

Clearance details

Applicant: Amico Lab, Inc.
Product code: Code GQI
Device class: Class 2
Regulation: 21 CFR 866.3175
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 ↗

Recent devices under product code GQI

K951800 — CMV IGG HUMAN SERUM CONTROLS1995-11-16
K952254 — ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS1995-11-16
K942171 — CMV EARLY ANTIGEN TEST1994-06-30
K883102 — VIRGO (R) CMV-IGG ELISA1989-02-08
K875159 — DETECTADOT SYSTEM 2000 CMV IGG TEST1988-05-06

More clearances from Amico Lab, Inc.

K842662 — ANTI-EPSTEIN-BARR VIRUS KIT1985-12-12
K842530 — AMIZYME-EBV TEST 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.