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FDA 510(k)

EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C

K-Number: K102779 · 2011-03-18

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2011-03-18
Product CodeDJG
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2011-03-18 under 510(k) number K102779. The device is classified under product code DJG. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C?

EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C is a medical device that received FDA 510(k) clearance on 2011-03-18. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K102779.

When did EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C receive FDA 510(k) clearance?

EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C received FDA 510(k) clearance on 2011-03-18, under 510(k) number K102779.

Who is the listed applicant for EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C?

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

What is the FDA product code for EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C?

The FDA product code for EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C is DJG.

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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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