MICRO21 WITH ANA

Device, Automated Cell-locating

TRIANGLE BIOMEDICAL SCIENCES, INC.

The following data is part of a premarket notification filed by Triangle Biomedical Sciences, Inc. with the FDA for Micro21 With Ana.

Pre-market Notification Details

Device IDK960774
510k NumberK960774
Device Name:MICRO21 WITH ANA
ClassificationDevice, Automated Cell-locating
Applicant TRIANGLE BIOMEDICAL SCIENCES, INC. 4360 NORTHLAKE BLVD. SUITE 214 Palm Beach Gardens,  FL  33410
ContactR. Otto Stellner
CorrespondentR. Otto Stellner
TRIANGLE BIOMEDICAL SCIENCES, INC. 4360 NORTHLAKE BLVD. SUITE 214 Palm Beach Gardens,  FL  33410
Product CodeJOY  
CFR Regulation Number864.5260 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-02-26
Decision Date1996-05-22
Summary:summary

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