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FDA 510(k)

EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS

K-Number: K955448 · 1996-02-23

ApplicantBehring Diagnostics, Inc.
Decision Date1996-02-23
Product CodeDLB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-02-23 under 510(k) number K955448. 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 EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS?

EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS is a medical device that received FDA 510(k) clearance on 1996-02-23. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K955448.

When did EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS receive FDA 510(k) clearance?

EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS received FDA 510(k) clearance on 1996-02-23, under 510(k) number K955448.

Who is the listed applicant for EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS?

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

What is the FDA product code for EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS?

The FDA product code for EMIT II LSD ASSAY, EMIT LSD CALIBRATORS & EMIT LSD CONTROLS is DLB.

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Other records listing Behring Diagnostics, Inc. as applicant

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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.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.K860525ABUSCREEN RADIOIMMUNOASSAY FOR LSD W/ REF STANDARDRoche 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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