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FDA 510(k)

MYCOPLASMELISA TEST KIT

K-Number: K823804 · 1983-05-25

ApplicantM.A. Bioproducts
Decision Date1983-05-25
Product CodeLJZ
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MYCOPLASMELISA TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is M.A. Bioproducts. It received FDA 510(k) clearance on 1983-05-25 under 510(k) number K823804. 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 MYCOPLASMELISA TEST KIT?

MYCOPLASMELISA TEST KIT is a medical device that received FDA 510(k) clearance on 1983-05-25. The listed applicant is M.A. Bioproducts. The 510(k) number is K823804.

When did MYCOPLASMELISA TEST KIT receive FDA 510(k) clearance?

MYCOPLASMELISA TEST KIT received FDA 510(k) clearance on 1983-05-25, under 510(k) number K823804.

Who is the listed applicant for MYCOPLASMELISA TEST KIT?

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

What is the FDA product code for MYCOPLASMELISA TEST KIT?

The FDA product code for MYCOPLASMELISA TEST KIT is LJZ.

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Other records listing M.A. Bioproducts 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.

K822883HERPELISA KITK830045MUMPSELISA TEST KITK830615CYTOMEGELISA STATK823805VARICELISA TEST KITK821967CHLAMYDELISA TEST KITK821762MEASELISA TEST KIT

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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

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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