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FDA 510(k)

MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE

K-Number: K983704 · 1999-02-10

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1999-02-10
Product CodeJCM
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1999-02-10 under 510(k) number K983704. The device is classified under product code JCM. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE?

MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE is a medical device that received FDA 510(k) clearance on 1999-02-10. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K983704.

When did MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE receive FDA 510(k) clearance?

MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE received FDA 510(k) clearance on 1999-02-10, under 510(k) number K983704.

Who is the listed applicant for MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE?

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

What is the FDA product code for MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE?

The FDA product code for MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE is JCM.

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Other records listing Roche Diagnostic Systems, Inc. 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.

K983698MODIFICATION TO ABUSCREEN ONLINE BARBITURATESK983702MODIFICATION TO ABUSCREEN ONLINE FOR BENZOIDIAZEPINESK983556ABUSCREEN ONLINE BENZ 300 CALIBRATORSK983555ABUSCREEN ONLINE BENZ 200 CALIBRATORSK983700MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENEK983697MODIFICATION TO ABUSCREEN ONLINE COCAINE METABOLITE

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Related Devices (Code: JCM)

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.

K053031EXTENDSURE HBFASC CONTROLCantebury Scientific , Ltd.K011389HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL)Canterbury Health LaboratoriesK942222QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLSIsolab, Inc.K933086AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328Helena LaboratoriesK931234HEMOCARD CONTROL HB-AA, AE, FAA, FAEIsolab, Inc.K924173HEMOCARD(TM) CONTROLIsolab, Inc.

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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