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FDA 510(k)

NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B

K-Number: K071649 · 2008-08-07

ApplicantWallac OY
Decision Date2008-08-07
Product CodeJIA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B is the device name listed in this FDA 510(k) record. The listed applicant is Wallac OY. It received FDA 510(k) clearance on 2008-08-07 under 510(k) number K071649. The device is classified under product code JIA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B?

NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B is a medical device that received FDA 510(k) clearance on 2008-08-07. The listed applicant is Wallac OY. The 510(k) number is K071649.

When did NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B receive FDA 510(k) clearance?

NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B received FDA 510(k) clearance on 2008-08-07, under 510(k) number K071649.

Who is the listed applicant for NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B?

The FDA 510(k) record lists Wallac OY as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B?

The FDA product code for NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110B is JIA.

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Other records listing Wallac OY as applicant

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Related Devices (Code: JIA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K190335GSP Neonatal Total Galactose kitPerkinelmer, Inc.K121101SPOTCHECK NEONATAL TOTAL GALACTOSE MICROPLATE REAGENT KITAstoria-Pacific, Inc.K990644QUANTASE TOTAL GALACTOSE SCREENING ASSAYQuantase , Ltd.K990654QUANTASE TOTAL GALACTOSE SCREENING ASSAY 500 TEST KITQuantase , Ltd.K991498ACCUWELL TOTAL GALACTOSE, MODEL 6010-EGALNeometrics, Inc.K950481NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KITIsolab, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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