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FDA 510(k)

DIATECH IGM-MP TEST

K-Number: K895276 · 1989-12-18

ApplicantDiatech Diagnostica , Ltd.
Decision Date1989-12-18
Product CodeLJZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

DIATECH IGM-MP TEST is the device name listed in this FDA 510(k) record. The listed applicant is Diatech Diagnostica , Ltd.. It received FDA 510(k) clearance on 1989-12-18 under 510(k) number K895276. The device is classified under product code LJZ. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIATECH IGM-MP TEST?

DIATECH IGM-MP TEST is a medical device that received FDA 510(k) clearance on 1989-12-18. The listed applicant is Diatech Diagnostica , Ltd.. The 510(k) number is K895276.

When did DIATECH IGM-MP TEST receive FDA 510(k) clearance?

DIATECH IGM-MP TEST received FDA 510(k) clearance on 1989-12-18, under 510(k) number K895276.

Who is the listed applicant for DIATECH IGM-MP TEST?

The FDA 510(k) record lists Diatech Diagnostica , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIATECH IGM-MP TEST?

The FDA product code for DIATECH IGM-MP TEST is LJZ.

Related Clinical Trials

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.

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Other records listing Diatech Diagnostica , Ltd. 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.

K882596MP TESTK882211URISCREEN

Related Devices (Code: LJZ)

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.

K984153THE APTUS (AUTOMATED) APPLICATION OF THE MYCOPLASMA IGM ELISA TEST SYSTEM.Zeus Scientific, Inc.K971503MYCOPLASMA IGM ELISA TEST SYSTEMZeus Scientific, Inc.K971393MYCOPLASMA IGG ELISA TEST SYSTEMImmunoprobe, Inc.K970150MYCOPLASMA IGG ELISA TEST SYSTEMZeus Scientific, Inc.K963054IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGM) TEST (3130)GenbioK963055IMMUNOWELL MYCOPLASMA PNEUMONIA ANTIBODY (IGG) TEST 3120Genbio

Official Source

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

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