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FDA 510(k)

AMIZYME-C TRACHOMATIS TEST KIT

K-Number: K842525 · 1984-10-01

ApplicantAmico Lab, Inc.
Decision Date1984-10-01
Product CodeLJP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

AMIZYME-C TRACHOMATIS 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 1984-10-01 under 510(k) number K842525. The device is classified under product code LJP. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMIZYME-C TRACHOMATIS TEST KIT?

AMIZYME-C TRACHOMATIS TEST KIT is a medical device that received FDA 510(k) clearance on 1984-10-01. The listed applicant is Amico Lab, Inc.. The 510(k) number is K842525.

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

AMIZYME-C TRACHOMATIS TEST KIT received FDA 510(k) clearance on 1984-10-01, under 510(k) number K842525.

Who is the listed applicant for AMIZYME-C TRACHOMATIS 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-C TRACHOMATIS TEST KIT?

The FDA product code for AMIZYME-C TRACHOMATIS TEST KIT is LJP.

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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 KITK842531AMIZYME-HSV TYPES 1 & 2 TEST KITSK842663ANTI-HERPES SIMPLEX VIRUS TYPE 1 OR 2K842530AMIZYME-EBV TEST KITK842529AMIZYME-CMV KITK842661ANTI-CYTOMEGALOVIRUS KIT

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Related Devices (Code: LJP)

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.

K063675DIAGNOSTIC HYBRIDS' D3 DFA CHLAMYDIAE CULTURE CONFIRMATION KITDiagnostic Hybrids, Inc.K941714CHLAMYDIA TRACHOMATIS ANTIGEN TESTNeogenexK901243CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TESTCel Labs Pty, Ltd.K900870PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TESTDiagnostic Products Corp.K895839PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1Diagnostic Products Corp.K883352FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTIWhittaker Bioproducts, 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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