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FDA 510(k)

PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)

K-Number: K893905 · 1989-08-03

ApplicantDiagnostic Products Corp.
Decision Date1989-08-03
Product CodeLIO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1) 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 1989-08-03 under 510(k) number K893905. The device is classified under product code LIO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)?

PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1) is a medical device that received FDA 510(k) clearance on 1989-08-03. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K893905.

When did PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1) receive FDA 510(k) clearance?

PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1) received FDA 510(k) clearance on 1989-08-03, under 510(k) number K893905.

Who is the listed applicant for PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)?

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(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1)?

The FDA product code for PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1) is LIO.

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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: LIO)

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.

K222613ARX Liquid Amies Collection & Transport SystemArx Sciences, Inc.K131630PURITAN AMIES MEDIUM COLLECTION AND TRANSPORT SYSTEMPuritan Medical Products, LLCK120846TRANSPORT CULTURE MEDIUM DEVICEPuritan Medical Products, LLCK103805MEDICAL WIRE & EQUIPMENT S-TRANSWAB (OR SIGMA-TRANSWAB) LIQUID AMIES COLLECTION AND TRANSPORT DEVICEMedical Wire & Equipment Company (Bath), Ltd.K082472VIROCULT, MODEL MW950Medical Wire & Equipment Company (Bath), Ltd.K070062COPROSET SALMONELLA AND SHIGELLA, URISET PRESERVATIVE TUBES AND SWAB SET GENERAL USEDiesse Diagnostica Senese S.P.A.

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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