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FDA 510(k)

ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD

K-Number: K860525 · 1986-04-11

ApplicantRoche Diagnostic Systems, Inc.
Decision Date1986-04-11
Product CodeDLB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD 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 1986-04-11 under 510(k) number K860525. The device is classified under product code DLB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD?

ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD is a medical device that received FDA 510(k) clearance on 1986-04-11. The listed applicant is Roche Diagnostic Systems, Inc.. The 510(k) number is K860525.

When did ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD receive FDA 510(k) clearance?

ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD received FDA 510(k) clearance on 1986-04-11, under 510(k) number K860525.

Who is the listed applicant for ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD?

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 RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD?

The FDA product code for ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARD is DLB.

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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: DLB)

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.

K961436ABUSCREEN ONLINE LSD REAGENT (90 ML TEST KIT)Roche Diagnostic Systems, Inc.K955448EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLSBehring Diagnostics, Inc.K955814CEDIA DAU LSD ASSAYMicrogenics Corp.K954073STC DIAGNOSTICS LSD MICRO-PLATE EIASolarcare Technologies Corp,Inc.K891167COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KITDiagnostic Products Corp.K874270REVISED LABELING FOR LSD TEST KITRoche Diagnostic Systems, 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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