VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET

Tubes, Vials, Systems, Serum Separators, Blood Collection

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 Vacutainer Brand Safety-lok Blood Collection Set Model Multiple, Vacutainer Brand Blood Collection Set.

Pre-market Notification Details

Device IDK980414
510k NumberK980414
Device Name:VACUTAINER BRAND SAFETY-LOK BLOOD COLLECTION SET MODEL MULTIPLE, VACUTAINER BRAND BLOOD COLLECTION SET
ClassificationTubes, Vials, Systems, Serum Separators, Blood Collection
Applicant BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes,  NJ  07417 -1880
ContactJohn Schalago
CorrespondentJohn Schalago
BD BECTON DICKINSON VACUTAINER SYSTEMS PREANALYTIC 1 BECTON DR. Franklin Lakes,  NJ  07417 -1880
Product CodeJKA  
CFR Regulation Number862.1675 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-03
Decision Date1998-03-03
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
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50382903686556 K980414 000
30382903686538 K980414 000
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30382903672968 K980414 000
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30382903672876 K980414 000
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50382903686549 K980414 000
00382903672813 K980414 000
50382903672979 K980414 000
50382903672962 K980414 000
00382903686537 K980414 000
00382903672875 K980414 000
00382903672837 K980414 000
00382903686520 K980414 000
00382903672981 K980414 000
00382903672974 K980414 000
00382903672967 K980414 000
00382903672943 K980414 000
00382903672929 K980414 000
00382903672851 K980414 000
30382903672814 K980414 000

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