URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)

Indicator Method, Protein Or Albumin (urinary, Non-quant.)

TECO DIAGNOSTICS

The following data is part of a premarket notification filed by Teco Diagnostics with the FDA for Urine Reagent Strips-3 Parameters (modification).

Pre-market Notification Details

Device IDK955438
510k NumberK955438
Device Name:URINE REAGENT STRIPS-3 PARAMETERS (MODIFICATION)
ClassificationIndicator Method, Protein Or Albumin (urinary, Non-quant.)
Applicant TECO DIAGNOSTICS 911 VIA RODEO Placentia,  CA  92670
ContactK C Chen
CorrespondentK C Chen
TECO DIAGNOSTICS 911 VIA RODEO Placentia,  CA  92670
Product CodeJIR  
CFR Regulation Number862.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1995-11-08
Decision Date1996-01-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00664816000052 K955438 000
20722355002181 K955438 000
10673486000283 K955438 000
10673486000276 K955438 000
10673486000269 K955438 000
10673486000238 K955438 000
10673486000221 K955438 000
10673486000214 K955438 000

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