GENZYME DIAGNOSTICS CONTRAST MONO— 510(k) K963425

Name: FDA 510(k) clearance K963425
Creator: U.S. Food and Drug Administration
Published: 1997-02-25

Substantially Equivalent

Genzyme Diagnostics

FDA 510(k) clearance K963425 for GENZYME DIAGNOSTICS CONTRAST MONO, Substantially Equivalent on 1997-02-25. Applicant: Genzyme Diagnostics. Device class: 2.

Clearance details

Applicant: Genzyme Diagnostics
Product code: Code KTN
Device class: Class 2
Regulation: 21 CFR 866.5640
Advisory panel: Immunology
Date received: 1996-08-30
Decision date: 1997-02-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Carlos, CA, US

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Recent devices under product code KTN

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K181436 — OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health Mono II Rapid Test2018-06-22
K042272 — ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA)2005-02-28
K030215 — BIORAPID MONONUCLEOSIS2003-02-24
K012901 — COLOR-MONOGEN2001-09-27
K982634 — DRYSPOT INFECTIOUS MONONUCLEOSIS KIT1999-01-28

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K964155 — CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST1996-11-25
K964156 — CONTRAST STRIP HCG1996-11-25

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