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FDA 510(k)

AMIZYME-CMV KIT

K-Number: K842529 · 1985-12-06

ApplicantAmico Lab, Inc.
Decision Date1985-12-06
Product CodeGQI
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AMIZYME-CMV 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 1985-12-06 under 510(k) number K842529. The device is classified under product code GQI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMIZYME-CMV KIT?

AMIZYME-CMV KIT is a medical device that received FDA 510(k) clearance on 1985-12-06. The listed applicant is Amico Lab, Inc.. The 510(k) number is K842529.

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

AMIZYME-CMV KIT received FDA 510(k) clearance on 1985-12-06, under 510(k) number K842529.

Who is the listed applicant for AMIZYME-CMV 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-CMV KIT?

The FDA product code for AMIZYME-CMV KIT is GQI.

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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 KITK842663ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2K842661ANTI-CYTOMEGALOVIRUS KITK842530AMIZYME-EBV TEST KITK842531AMIZYME-HSV TYPES 1 & 2 TEST KITSK842660ANTI-SCHISTOSOMA SPECIES KIT

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Related Devices (Code: GQI)

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.

K952254ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUSPyramid Biological Corp.K951800CMV IGG HUMAN SERUM CONTROLSPyramid Biological Corp.K942171CMV EARLY ANTIGEN TESTNeogenexK883102VIRGO (R) CMV-IGG ELISAElectro-Nucleonics, Inc.K875159DETECTADOT SYSTEM 2000 CMV IGG TESTGull Laboratories, Inc.K863488ENZYGNOST ANTI-CMV IGG TESTBehring Diagnostics, 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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