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FDA 510(k)

GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY

K-Number: K983399 · 1999-01-11

ApplicantGenzyme Diagnostics
Decision Date1999-01-11
Product CodeMHI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Genzyme Diagnostics. It received FDA 510(k) clearance on 1999-01-11 under 510(k) number K983399. The device is classified under product code MHI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY?

GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY is a medical device that received FDA 510(k) clearance on 1999-01-11. The listed applicant is Genzyme Diagnostics. The 510(k) number is K983399.

When did GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY receive FDA 510(k) clearance?

GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY received FDA 510(k) clearance on 1999-01-11, under 510(k) number K983399.

Who is the listed applicant for GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY?

The FDA 510(k) record lists Genzyme Diagnostics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY?

The FDA product code for GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY is MHI.

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Other records listing Genzyme Diagnostics as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K043385OSOM HCG COMBO TESTK963425GENZYME DIAGNOSTICS CONTRAST MONOK964156CONTRAST STRIP HCGK964155CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST

Related Devices (Code: MHI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K120001UNIGOLD GIARDIATrinity BiotechK103673GIARDIA/ CRYPTOSPORIDIUM QUIK CHEKTechlab Inc., Corporate Research CenterK081064GIARDIA FECAL ANTIGEN DETECTION LATERAL FLOW KIT, MODEL GL-LFIvd Research, Inc.K031942XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020Remel, Inc.K031834XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAYRemel, Inc.K033274GIARDIA IITechlab, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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