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FDA 510(k)

PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST

K-Number: K900870 · 1990-04-16

ApplicantDiagnostic Products Corp.
Decision Date1990-04-16
Product CodeLJP
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Products Corp.. It received FDA 510(k) clearance on 1990-04-16 under 510(k) number K900870. 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 PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST?

PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST is a medical device that received FDA 510(k) clearance on 1990-04-16. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K900870.

When did PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST receive FDA 510(k) clearance?

PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST received FDA 510(k) clearance on 1990-04-16, under 510(k) number K900870.

Who is the listed applicant for PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST?

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

What is the FDA product code for PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST?

The FDA product code for PATHODX CHLAMYDIA TRACHOMATIS DIRECT SPECIMEN TEST is LJP.

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Other records listing Diagnostic Products 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.

K063045IMMULITE 2000, IMMULITE 2500 VANCOMYCINK034055IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN IK033234IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZERK032881IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONEK023152IMMULITE 2000 ALLERGEN-SPECIFIC IGEK023304IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL

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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.K895839PATHODX CHLAMYDIA CULTURE CONFIRMATION PKCC1Diagnostic Products Corp.K883352FLUORESCEIN CONJUGATED ANTI-CHLAMYDIA MONO ANTIWhittaker Bioproducts, Inc.K881500ORTHO* CHLAMYDIA DIRECT DETECTION (FA) TESTOrtho Diagnostic Systems, 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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