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FDA 510(k)

ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR

K-Number: K962280 · 1996-08-16

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1996-08-16
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR 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 1996-08-16 under 510(k) number K962280. The device is classified under product code DLJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR?

ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR is a medical device that received FDA 510(k) clearance on 1996-08-16. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K962280.

When did ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR receive FDA 510(k) clearance?

ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR received FDA 510(k) clearance on 1996-08-16, under 510(k) number K962280.

Who is the listed applicant for ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR?

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 ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR?

The FDA product code for ABUSCREEN ONLINE POSITIVE CONTROL / 1.5X CALIBRATOR is DLJ.

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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 BENZOIDIAZEPINESK983704MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINEK983556ABUSCREEN ONLINE BENZ 300 CALIBRATORSK983555ABUSCREEN ONLINE BENZ 200 CALIBRATORSK983700MODIFICATION TO ABUSCREEN ONLINE FOR PROPOXYPHENE

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Related Devices (Code: DLJ)

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.

K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher ScientificK082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, Inc.K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)Dade Behring, 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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