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FDA 510(k)

LABELING CHANGE COAT-A-COUNT METHAQUALONE

K-Number: K873759 · 1987-10-15

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

Device Summary

LABELING CHANGE COAT-A-COUNT METHAQUALONE 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 K873759. The device is classified under product code KXS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LABELING CHANGE COAT-A-COUNT METHAQUALONE?

LABELING CHANGE COAT-A-COUNT METHAQUALONE 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 K873759.

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

LABELING CHANGE COAT-A-COUNT METHAQUALONE received FDA 510(k) clearance on 1987-10-15, under 510(k) number K873759.

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

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 METHAQUALONE?

The FDA product code for LABELING CHANGE COAT-A-COUNT METHAQUALONE is KXS.

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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: KXS)

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.

K011164MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSR9Q229Syva Co., Dade Behring, Inc.K993986SYVA EMIT II PLUS METHAQUALONE ASSAY, MODEL 9Q029UL/9Q129ULSyva Co.K955676SYNCHRON SYSTEMS METHAQUALONE REAGENTBeckman Instruments, Inc.K945187ROCHE ABUSCREEN ONLINE FOR METHAQUALONERoche Diagnostic Systems, Inc.K940123METHAQUALONE ENZYME IMMUNOASSAYDiagnostic Reagents, Inc.K921013SYVA EMIT II METHAQUALONE ASSAYSyva Co.

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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