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FDA 510(k)

THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT

K-Number: K863913 · 1987-03-19

ApplicantDiagnostic Products Corp.
Decision Date1987-03-19
Product CodeDOE
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

THE DPC COAT-A-COUNT SERUM MORPHINE 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 1987-03-19 under 510(k) number K863913. The device is classified under product code DOE. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT?

THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT is a medical device that received FDA 510(k) clearance on 1987-03-19. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K863913.

When did THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT receive FDA 510(k) clearance?

THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT received FDA 510(k) clearance on 1987-03-19, under 510(k) number K863913.

Who is the listed applicant for THE DPC COAT-A-COUNT SERUM MORPHINE 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 THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT?

The FDA product code for THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT is DOE.

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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.

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Related Devices (Code: DOE)

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.

K010080INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TESTAlfa Scientific Designs, Inc.K010079INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TESTAlfa Scientific Designs, Inc.K011011LIVESURE MORPHINE SCREEN TESTPan Probe Biotech, Inc.K002418BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133DBranan Medical CorporationK951319ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATIONRoche Diagnostic Systems, Inc.K935055ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF)Roche 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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