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FDA 510(k)

SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT

K-Number: K851033 · 1985-06-21

ApplicantSyncor Intl. Corp.
Decision Date1985-06-21
Product CodeLJP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT is the device name listed in this FDA 510(k) record. The listed applicant is Syncor Intl. Corp.. It received FDA 510(k) clearance on 1985-06-21 under 510(k) number K851033. 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 SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT?

SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT is a medical device that received FDA 510(k) clearance on 1985-06-21. The listed applicant is Syncor Intl. Corp.. The 510(k) number is K851033.

When did SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT receive FDA 510(k) clearance?

SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT received FDA 510(k) clearance on 1985-06-21, under 510(k) number K851033.

Who is the listed applicant for SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT?

The FDA 510(k) record lists Syncor Intl. Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT?

The FDA product code for SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT is LJP.

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Other records listing Syncor Intl. Corp. 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.

K945825SECURE SAFETY INSERTK851828IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-CK850433CESIUM 137 ENDOMETRIAL SOURCEK852023CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41K852665SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAYK844735PTH-RIA

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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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