SPINAL FLUID CONTROL

Multi-analyte Controls, All Kinds (assayed)

IRVINE SCIENTIFIC

The following data is part of a premarket notification filed by Irvine Scientific with the FDA for Spinal Fluid Control.

Pre-market Notification Details

Device IDK851820
510k NumberK851820
Device Name:SPINAL FLUID CONTROL
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana,  CA  92705
ContactErnest S Johnson
CorrespondentErnest S Johnson
IRVINE SCIENTIFIC 2511 DAIMLER ST. Santa Ana,  CA  92705
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-04-26
Decision Date1985-07-15

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