GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY— 510(k) K983399

Name: FDA 510(k) clearance K983399
Creator: U.S. Food and Drug Administration
Published: 1999-01-11

Substantially Equivalent

Genzyme Diagnostics

FDA 510(k) clearance K983399 for GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY, Substantially Equivalent on 1999-01-11. Applicant: Genzyme Diagnostics. Device class: 2.

Clearance details

Applicant: Genzyme Diagnostics
Product code: Code MHI
Device class: Class 2
Regulation: 21 CFR 866.3220
Advisory panel: Microbiology
Date received: 1998-09-28
Decision date: 1999-01-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MHI

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K120001 — UNIGOLD GIARDIA2013-03-01
K103673 — GIARDIA/ CRYPTOSPORIDIUM QUIK CHEK2011-08-18
K081064 — GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LF2009-01-14
K031942 — XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 24500202003-11-18
K031834 — XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY2003-11-10

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

Recalls naming K983399

K-number listed on FDA's recall record

Z-1719-2025 — Meridian Bioscience ImmunoCard STAT! Crypto/Giardia Test Kits, Model Number 750830Class II·Ongoing·MEDLINE INDUSTRIES, LP - Northfield·20250324

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K983399.

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