AXSYM INTACT PTH, MODEL 2G06

Radioimmunoassay, Parathyroid Hormone

DIAGNOSTIC SYSTEMS LABORATORIES, INC.

The following data is part of a premarket notification filed by Diagnostic Systems Laboratories, Inc. with the FDA for Axsym Intact Pth, Model 2g06.

Pre-market Notification Details

Device IDK020945
510k NumberK020945
Device Name:AXSYM INTACT PTH, MODEL 2G06
ClassificationRadioimmunoassay, Parathyroid Hormone
Applicant DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
ContactCarroll Potts
CorrespondentCarroll Potts
DIAGNOSTIC SYSTEMS LABORATORIES, INC. 445 MEDICAL CENTER BLVD. Webster,  TX  77598
Product CodeCEW  
Subsequent Product CodeJIT
Subsequent Product CodeJIX
CFR Regulation Number862.1545 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-03-25
Decision Date2002-05-31
Summary:summary

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