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FDA 510(k)

MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT

K-Number: K871278 · 1987-04-08

ApplicantCalifornia Integrated Diagnostics, Inc.
Decision Date1987-04-08
Product CodeLJP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is California Integrated Diagnostics, Inc.. It received FDA 510(k) clearance on 1987-04-08 under 510(k) number K871278. 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 MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT?

MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT is a medical device that received FDA 510(k) clearance on 1987-04-08. The listed applicant is California Integrated Diagnostics, Inc.. The 510(k) number is K871278.

When did MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT receive FDA 510(k) clearance?

MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT received FDA 510(k) clearance on 1987-04-08, under 510(k) number K871278.

Who is the listed applicant for MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT?

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

What is the FDA product code for MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT?

The FDA product code for MODIFIED CHLAMYDIA DIRECT SPECIMEN TEST KIT is LJP.

Related Clinical Trials

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Other records listing California Integrated Diagnostics, 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.

K904095HERPES SIMPLEX VIRUS TISSUE CULTURE CONF. TYPINGK874259TRICHOMONAS DIRECT ENZYME IMMUNOASSAYK871279MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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