TUBING KIT 446

Analyzer, Chemistry (photometric, Discrete), For Clinical Use

SHABAN MFG. CO.

The following data is part of a premarket notification filed by Shaban Mfg. Co. with the FDA for Tubing Kit 446.

Pre-market Notification Details

Device IDK832584
510k NumberK832584
Device Name:TUBING KIT 446
ClassificationAnalyzer, Chemistry (photometric, Discrete), For Clinical Use
Applicant SHABAN MFG. CO. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJJE  
CFR Regulation Number862.2160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1983-08-02
Decision Date1983-09-12

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