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FDA 510(k)

AMIZYME-ANA TEST KIT

K-Number: K842532 · 1984-09-20

ApplicantAmico Lab, Inc.
Decision Date1984-09-20
Product CodeLJM
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

AMIZYME-ANA TEST 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 1984-09-20 under 510(k) number K842532. The device is classified under product code LJM. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMIZYME-ANA TEST KIT?

AMIZYME-ANA TEST KIT is a medical device that received FDA 510(k) clearance on 1984-09-20. The listed applicant is Amico Lab, Inc.. The 510(k) number is K842532.

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

AMIZYME-ANA TEST KIT received FDA 510(k) clearance on 1984-09-20, under 510(k) number K842532.

Who is the listed applicant for AMIZYME-ANA TEST 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-ANA TEST KIT?

The FDA product code for AMIZYME-ANA TEST KIT is LJM.

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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: LJM)

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.

K182353EliA CENP Immunoassay, EliA U1RNP Immunoassay, EliA RNP70 ImmunoassayPhadia ABK151559ImmuLisa Enhanced Centromere Antibody ELISAImmco Diagnostics, Inc.K131185ANA SCREEN ELISA (IGG)Euroimmun USK083188VARELISA RECOMBI ANA SCREEN, MODEL 12 596Phadia US, Inc.K050967VARELISA RECOMBI CTD SCREEN, MODEL 13096Sweden Diagnostics (Germany) GmbHK050625VARELISA RECOMBI ANA PROFILE, MODEL 18496Sweden Diagnostics (Germany) GmbH

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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