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FDA 510(k)

CHLAMYSET ANTIGEN

K-Number: K853401 · 1986-04-28

ApplicantOrion Corp.
Decision Date1986-04-28
Product CodeLJP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

CHLAMYSET ANTIGEN is the device name listed in this FDA 510(k) record. The listed applicant is Orion Corp.. It received FDA 510(k) clearance on 1986-04-28 under 510(k) number K853401. 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 CHLAMYSET ANTIGEN?

CHLAMYSET ANTIGEN is a medical device that received FDA 510(k) clearance on 1986-04-28. The listed applicant is Orion Corp.. The 510(k) number is K853401.

When did CHLAMYSET ANTIGEN receive FDA 510(k) clearance?

CHLAMYSET ANTIGEN received FDA 510(k) clearance on 1986-04-28, under 510(k) number K853401.

Who is the listed applicant for CHLAMYSET ANTIGEN?

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

What is the FDA product code for CHLAMYSET ANTIGEN?

The FDA product code for CHLAMYSET ANTIGEN is LJP.

Related Clinical Trials

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Other records listing Orion 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.

K912391RUBALEX, MODIFICATIONK901637RESUBMITTED MODIFIED RUBALEXK884650RESUBMITTED SCANORAK890199DENTOCULT SM-STRIP MUTANSK881506MAMEX DC MAG MG12K881505MAMEX DC MG11

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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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