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FDA 510(k)

AMIZYME-TOXOPLASMA GONDII KIT

K-Number: K842528 · 1984-09-07

ApplicantAmico Lab, Inc.
Decision Date1984-09-07
Product CodeLGD
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AMIZYME-TOXOPLASMA GONDII KIT is the device name listed in this FDA 510(k) record. The listed applicant is Amico Lab, Inc.. It received FDA 510(k) clearance on 1984-09-07 under 510(k) number K842528. The device is classified under product code LGD. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMIZYME-TOXOPLASMA GONDII KIT?

AMIZYME-TOXOPLASMA GONDII KIT is a medical device that received FDA 510(k) clearance on 1984-09-07. The listed applicant is Amico Lab, Inc.. The 510(k) number is K842528.

When did AMIZYME-TOXOPLASMA GONDII KIT receive FDA 510(k) clearance?

AMIZYME-TOXOPLASMA GONDII KIT received FDA 510(k) clearance on 1984-09-07, under 510(k) number K842528.

Who is the listed applicant for AMIZYME-TOXOPLASMA GONDII KIT?

The FDA 510(k) record lists Amico Lab, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for AMIZYME-TOXOPLASMA GONDII KIT?

The FDA product code for AMIZYME-TOXOPLASMA GONDII KIT is LGD.

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Other records listing Amico Lab, Inc. 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.

K842662ANTI-EPSTEIN-BARR VIRUS KITK842530AMIZYME-EBV TEST KITK842663ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2K842531AMIZYME-HSV TYPES 1 & 2 TEST KITSK842529AMIZYME-CMV KITK842661ANTI-CYTOMEGALOVIRUS KIT

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Related Devices (Code: LGD)

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.

K242022Access Toxo IgGBeckman Coulter, Inc.K242095Access Toxo IgM IIBeckman Coulter, Inc.K233932Alinity i Toxo IgMAbbott LaboratoriesK210596ARCHITECT Toxo IgGAbbott LaboratoriesK162678Elecsys Toxo IgM, Elecsys Toxo IgM PreciControlRoche DiagnosticsK132234LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG IIDiaSorin, 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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