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

Enzyme Immunoassay, Opiates

Siemens Healthcare Diagnostics Inc.

The following data is part of a premarket notification filed by Siemens Healthcare Diagnostics Inc. with the FDA for Emit Ii Plus6-acetylmorphine Assay; Emit Ii Plus 6-am/ Ecstasy Calibrator/ Control Level 1; Emit Ii Plus 6-am / Ectasy C.

Pre-market Notification Details

Device IDK102779
510k NumberK102779
Device Name:EMIT II PLUS6-ACETYLMORPHINE ASSAY; EMIT II PLUS 6-AM/ ECSTASY CALIBRATOR/ CONTROL LEVEL 1; EMIT II PLUS 6-AM / ECTASY C
ClassificationEnzyme Immunoassay, Opiates
Applicant Siemens Healthcare Diagnostics Inc. P.O. BOX 6101 MAILBOX 514 Newark,  DE  19714
ContactJanet M Fose
CorrespondentJanet M Fose
Siemens Healthcare Diagnostics Inc. P.O. BOX 6101 MAILBOX 514 Newark,  DE  19714
Product CodeDJG  
Subsequent Product CodeDIF
Subsequent Product CodeDKB
CFR Regulation Number862.3650 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2010-09-24
Decision Date2011-03-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00842768034169 K102779 000
00842768034152 K102779 000
00842768034145 K102779 000
00842768034138 K102779 000
00842768034121 K102779 000
00842768034114 K102779 000
00630414229591 K102779 000

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