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FDA 510(k)

LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE

K-Number: K873751 · 1987-10-15

ApplicantDiagnostic Products Corp.
Decision Date1987-10-15
Product CodeDIO
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE 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 1987-10-15 under 510(k) number K873751. The device is classified under product code DIO. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE?

LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE is a medical device that received FDA 510(k) clearance on 1987-10-15. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K873751.

When did LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE receive FDA 510(k) clearance?

LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE received FDA 510(k) clearance on 1987-10-15, under 510(k) number K873751.

Who is the listed applicant for LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE?

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 LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE?

The FDA product code for LABELING CHANGE COAT-A-COUNT COCAINE METABOLITE is DIO.

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Other records listing Diagnostic Products Corp. as applicant

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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: DIO)

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.

K213211Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test SystemCarolina Liquid Chemistries Corp.K211973DRI Cocaine Metabolite AssayMicrogenics CorporationK191638Pointe Scientific Cocaine Metabolite Enzyme ImmunoassayMedtest DXK181499DRI Cocaine Metabolite AssayMicrogenics CorporationK170293Emit II Plus Cocaine Metabolite AssaySiemens Healthcare Diagnostics, Inc.K163570Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Test System (COCM)Carolina Liquid Chemistries Corporation

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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