SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE

Tube, Collection, Capillary Blood

SAFE-TEC CLINICAL PRODUCTS, INC.

The following data is part of a premarket notification filed by Safe-tec Clinical Products, Inc. with the FDA for Safe-tec Capillary Blood Collection Tube.

Pre-market Notification Details

Device IDK884623
510k NumberK884623
Device Name:SAFE-TEC CAPILLARY BLOOD COLLECTION TUBE
ClassificationTube, Collection, Capillary Blood
Applicant SAFE-TEC CLINICAL PRODUCTS, INC. NORTHAMPTON INDUSTRIAL PARK 163 RAILROAD DRIVE Ivyland,  PA  18974
ContactG Kendrick
CorrespondentG Kendrick
SAFE-TEC CLINICAL PRODUCTS, INC. NORTHAMPTON INDUSTRIAL PARK 163 RAILROAD DRIVE Ivyland,  PA  18974
Product CodeGIO  
CFR Regulation Number864.6150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-11-04
Decision Date1988-12-01

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
30382904203185 K884623 000
30382904203178 K884623 000
30382904203161 K884623 000
30382904203154 K884623 000
30382904203147 K884623 000
00868556000222 K884623 000

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