KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD

Calibrator, Primary

KING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by King Diagnostics, Inc. with the FDA for King Diagnostics Sodium/potassium Standard.

Pre-market Notification Details

Device IDK920809
510k NumberK920809
Device Name:KING DIAGNOSTICS SODIUM/POTASSIUM STANDARD
ClassificationCalibrator, Primary
Applicant KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis,  IN  46220
ContactFrances Loh
CorrespondentFrances Loh
KING DIAGNOSTICS, INC. 6856 HAWTHORN PARK DR. Indianapolis,  IN  46220
Product CodeJIS  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1992-02-21
Decision Date1992-04-17

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