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FDA 510(k)

LABELING CHANGES COAT-A-COUNT METHADONE IN URINE

K-Number: K873750 · 1987-10-15

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

Device Summary

LABELING CHANGES COAT-A-COUNT METHADONE IN URINE 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 K873750. The device is classified under product code DJR. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LABELING CHANGES COAT-A-COUNT METHADONE IN URINE?

LABELING CHANGES COAT-A-COUNT METHADONE IN URINE 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 K873750.

When did LABELING CHANGES COAT-A-COUNT METHADONE IN URINE receive FDA 510(k) clearance?

LABELING CHANGES COAT-A-COUNT METHADONE IN URINE received FDA 510(k) clearance on 1987-10-15, under 510(k) number K873750.

Who is the listed applicant for LABELING CHANGES COAT-A-COUNT METHADONE IN URINE?

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 CHANGES COAT-A-COUNT METHADONE IN URINE?

The FDA product code for LABELING CHANGES COAT-A-COUNT METHADONE IN URINE is DJR.

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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: DJR)

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.

K192433LZI Methadone II Enzyme ImmunoassayLin-Zhi International, Inc.K182779ARK EDDP AssayArk Diagnostics, Inc.K170416LZI Methadone Metabolite Enzyme Immunoassay, LZI Methadone Metabolite (100 and 300) CalibratorsLin-Zhi International, Inc.K160793First Sign Drug of Abuse Dip Card Test (MDMA, EDDP, Nortriptyline), First Sign Drug of Abuse Cup Test (MDMA, EDDP, Nortriptyline)W.H.P.M., Inc.K131232WONDFO METHADONE URINE TEST (MTD 200), WONDOFO MORPHINE URINE TEST (MOP 100)Guangzhou Wondfo Biotech Co., Ltd.K092272RANDOX METHADONE ASSAYRandox Laboratories, Ltd.

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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