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FDA 510(k)

COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5

K-Number: K874808 · 1988-02-18

ApplicantDiagnostic Products Corp.
Decision Date1988-02-18
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5 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 1988-02-18 under 510(k) number K874808. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5?

COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5 is a medical device that received FDA 510(k) clearance on 1988-02-18. The listed applicant is Diagnostic Products Corp.. The 510(k) number is K874808.

When did COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5 receive FDA 510(k) clearance?

COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5 received FDA 510(k) clearance on 1988-02-18, under 510(k) number K874808.

Who is the listed applicant for COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5?

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 COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5?

The FDA product code for COAT-A-COUNT OPIATES SCREEN TKOS1, TKOS5 is DJG.

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Other records listing Diagnostic Products Corp. as applicant

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Related Devices (Code: DJG)

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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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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