ANTI-LEU-4 FITC LYSIN C BUFFER

Assay, T Lymphocyte Surface Marker

BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC

The following data is part of a premarket notification filed by Bd Becton Dickinson Vacutainer Systems Preanalytic with the FDA for Anti-leu-4 Fitc Lysin C Buffer.

Pre-market Notification Details

Device IDK842218
510k NumberK842218
Device Name:ANTI-LEU-4 FITC LYSIN C BUFFER
ClassificationAssay, T Lymphocyte Surface Marker
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington,  DC  20006
ContactRussell J Arnsberge
CorrespondentRussell J Arnsberge
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1875 EYE ST. NW STE. 625 Washington,  DC  20006
Product CodeLIZ  
CFR Regulation Number864.5220 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1984-06-04
Decision Date1984-12-27

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00382903492015 K842218 000
00382903405428 K842218 000

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