STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01

Centrifuges (micro, Ultra, Refrigerated) For Clinical Use

NORFOLK SCIENTIFIC, INC.

The following data is part of a premarket notification filed by Norfolk Scientific, Inc. with the FDA for Statspin Disposable Rotor, Product #rd01.

Pre-market Notification Details

Device IDK881254
510k NumberK881254
Device Name:STATSPIN DISPOSABLE ROTOR, PRODUCT #RD01
ClassificationCentrifuges (micro, Ultra, Refrigerated) For Clinical Use
Applicant NORFOLK SCIENTIFIC, INC. 85 MORSE ST. Norwood,  MA  02062
ContactThomas F Kelley,phd
CorrespondentThomas F Kelley,phd
NORFOLK SCIENTIFIC, INC. 85 MORSE ST. Norwood,  MA  02062
Product CodeJQC  
CFR Regulation Number862.2050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-23
Decision Date1988-04-05

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.