IS-ANTI-SM/RNP (720-270)

Extractable Antinuclear Antibody, Antigen And Control

DIAMEDIX CORP.

The following data is part of a premarket notification filed by Diamedix Corp. with the FDA for Is-anti-sm/rnp (720-270).

Pre-market Notification Details

Device IDK970238
510k NumberK970238
Device Name:IS-ANTI-SM/RNP (720-270)
ClassificationExtractable Antinuclear Antibody, Antigen And Control
Applicant DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
ContactLynne Stirling, Ph.d.
CorrespondentLynne Stirling, Ph.d.
DIAMEDIX CORP. 2140 NORTH MIAMI AVE. Miami,  FL  33127
Product CodeLLL  
CFR Regulation Number866.5100 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-01-21
Decision Date1997-04-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00817273020105 K970238 000
B3507202700 K970238 000

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