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FDA 510(k)

RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016

K-Number: K030211 · 2003-06-13

ApplicantIcn Biomedicals, Inc.
Decision Date2003-06-13
Product CodeDKX
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 is the device name listed in this FDA 510(k) record. The listed applicant is Icn Biomedicals, Inc.. It received FDA 510(k) clearance on 2003-06-13 under 510(k) number K030211. The device is classified under product code DKX. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016?

RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 is a medical device that received FDA 510(k) clearance on 2003-06-13. The listed applicant is Icn Biomedicals, Inc.. The 510(k) number is K030211.

When did RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 receive FDA 510(k) clearance?

RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 received FDA 510(k) clearance on 2003-06-13, under 510(k) number K030211.

Who is the listed applicant for RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016?

The FDA 510(k) record lists Icn Biomedicals, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016?

The FDA product code for RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016 is DKX.

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Other records listing Icn Biomedicals, Inc. as applicant

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K023252RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020K926106IMMUCHEM PHE-MW EAK922944IMMUCHEM LH-MW ELISAK922376ICN BIOMEDICALS IMMUCHEM(TM) FSH-MW ELISA KITK922715IMMUCHEM PRL-MW ELISAK920442IMMUCHEM TSH-MW ELISA

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Related Devices (Code: DKX)

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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