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FDA 510(k)

GSP NEONATAL BIOTINIDASE KIT

K-Number: K131284 · 2013-11-14

ApplicantWallac OY
Decision Date2013-11-14
Product CodeNAK
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GSP NEONATAL BIOTINIDASE KIT is the device name listed in this FDA 510(k) record. The listed applicant is Wallac OY. It received FDA 510(k) clearance on 2013-11-14 under 510(k) number K131284. The device is classified under product code NAK. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GSP NEONATAL BIOTINIDASE KIT?

GSP NEONATAL BIOTINIDASE KIT is a medical device that received FDA 510(k) clearance on 2013-11-14. The listed applicant is Wallac OY. The 510(k) number is K131284.

When did GSP NEONATAL BIOTINIDASE KIT receive FDA 510(k) clearance?

GSP NEONATAL BIOTINIDASE KIT received FDA 510(k) clearance on 2013-11-14, under 510(k) number K131284.

Who is the listed applicant for GSP NEONATAL BIOTINIDASE KIT?

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 GSP NEONATAL BIOTINIDASE KIT?

The FDA product code for GSP NEONATAL BIOTINIDASE KIT is NAK.

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Other records listing Wallac OY as applicant

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.

K100682GSP NEONATAL 17A-OH-PROGESTERONE KIT MODEL: 3305-001UK081922AUTODELFIA NEONATAL 17A-OH-PROGESTERONE KITK071649NEONATAL TOTAL GALACTOSE KIT; NEONTAL TOTAL GALACTOSE KIT, MODELS 3029-0010 AND 3029-110BK070889AUTODELFIA NEONATAL IRT L KIT, MODEL B022-112K050709RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367K050960MODIFICATION TO: AUTODELFIA NEONATAL 17A-OH-PROGESTERONE L KIT

View all 21 devices →

Related Devices (Code: NAK)

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.

K090123NEONATAL BIOTINIDASE KIT, MODEL 3018Perkinelmer, Inc.K080294ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE MICROPLATE REAGENT KITAstoria-Pacific, Inc.K010844ASTORIA-PACIFIC SPOTCHECK BIOTINIDASE KIT, 50 HOUR, PART NO. 80-8000-13KAstoria-Pacific, 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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