UREA NITROGEN(BUN), COLORIMETRIC METHOD

Berthelot Indophenol, Urea Nitrogen

TECH-CO, INC.

The following data is part of a premarket notification filed by Tech-co, Inc. with the FDA for Urea Nitrogen(bun), Colorimetric Method.

Pre-market Notification Details

Device IDK864742
510k NumberK864742
Device Name:UREA NITROGEN(BUN), COLORIMETRIC METHOD
ClassificationBerthelot Indophenol, Urea Nitrogen
Applicant TECH-CO, INC. 4378 REILLY Troy,  MI  48098
ContactHappy Chen
CorrespondentHappy Chen
TECH-CO, INC. 4378 REILLY Troy,  MI  48098
Product CodeCDL  
CFR Regulation Number862.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-12-04
Decision Date1987-01-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
10673486001273 K864742 000
10673486001266 K864742 000

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