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FDA 510(k)

DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT

K-Number: K862218 · 1986-06-27

ApplicantDiagnostic Products Corp.
Decision Date1986-06-27
Product CodeKLN
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT 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 1986-06-27 under 510(k) number K862218. The device is classified under product code KLN. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT?

DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT is a medical device that received FDA 510(k) clearance on 1986-06-27. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K862218.

When did DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT receive FDA 510(k) clearance?

DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT received FDA 510(k) clearance on 1986-06-27, under 510(k) number K862218.

Who is the listed applicant for DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT?

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 DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT?

The FDA product code for DOUBLE ANTIBODY COCAINE METABOLITE RIA KIT is KLN.

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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

View all 321 devices →

Related Devices (Code: KLN)

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.

K010868PSYCHEMEDICS RIA COCAINE ASSAYPsychemedics Corp.K913867URINE COCAINE METABOLITE DIRECT RIA KIT (I-125)Immunalysis CorporationK913722ABUSCREEN(R) RADIOIMMUN FOR COCAINE METABOLITERoche Diagnostic Systems, Inc.K912756ABUSCREEN RADIOIMMUNOASSAY FOR COCAINE METABOLITERoche Diagnostic Systems, Inc.K910123TARGET COCAINE METABOLITE-VV-Tech, Inc.K910122TARGET COCAINE METABOLITE-RV-Tech, 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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