(FPIA) ASSAY BUFFER

Analyzer, Chemistry, Micro, For Clinical Use

WINDSOR LABORATORIES, INC.

The following data is part of a premarket notification filed by Windsor Laboratories, Inc. with the FDA for (fpia) Assay Buffer.

Pre-market Notification Details

Device IDK871486
510k NumberK871486
Device Name:(FPIA) ASSAY BUFFER
ClassificationAnalyzer, Chemistry, Micro, For Clinical Use
Applicant WINDSOR LABORATORIES, INC. P.O. BOX 475487 Garland,  TX  75047
ContactGuy W Rucker
CorrespondentGuy W Rucker
WINDSOR LABORATORIES, INC. P.O. BOX 475487 Garland,  TX  75047
Product CodeJJF  
CFR Regulation Number862.2170 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-04-15
Decision Date1987-05-08

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