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FDA 510(k)

EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229

K-Number: K011306 · 2001-05-16

ApplicantSyva Co., Dade Behring, Inc.
Decision Date2001-05-16
Product CodeJXM
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 is the device name listed in this FDA 510(k) record. The listed applicant is Syva Co., Dade Behring, Inc.. It received FDA 510(k) clearance on 2001-05-16 under 510(k) number K011306. The device is classified under product code JXM. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229?

EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 is a medical device that received FDA 510(k) clearance on 2001-05-16. The listed applicant is Syva Co., Dade Behring, Inc.. The 510(k) number is K011306.

When did EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 receive FDA 510(k) clearance?

EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 received FDA 510(k) clearance on 2001-05-16, under 510(k) number K011306.

Who is the listed applicant for EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229?

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

What is the FDA product code for EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229?

The FDA product code for EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229 is JXM.

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Other records listing Syva Co., Dade Behring, Inc. as applicant

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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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