RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367

Abnormal Hemoglobin Quantitation

WALLAC OY

The following data is part of a premarket notification filed by Wallac Oy with the FDA for Resolve Hemoglobin Kit, Jb-2 Staining System, Models Fr-9120, Fr-9400, Fr-9360, Fr-9367.

Pre-market Notification Details

Device IDK050709
510k NumberK050709
Device Name:RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367
ClassificationAbnormal Hemoglobin Quantitation
Applicant WALLAC OY MUSTIONKATU 6 Turku,  FI 20750
ContactRaija Koskivaara
CorrespondentRaija Koskivaara
WALLAC OY MUSTIONKATU 6 Turku,  FI 20750
Product CodeGKA  
CFR Regulation Number864.7415 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-03-18
Decision Date2006-03-08
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
06438147246137 K050709 000
06438147246120 K050709 000
06438147000814 K050709 000
06438147000807 K050709 000
06438147000791 K050709 000
06438147000784 K050709 000

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