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FDA 510(k)

GSP NEONATAL IRT KIT (3306-001U)

K-Number: K102419 · 2010-12-16

ApplicantWallac Oy, Subsidiary of Perkinelmer
Decision Date2010-12-16
Product CodeJNO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

GSP NEONATAL IRT KIT (3306-001U) is the device name listed in this FDA 510(k) record. The listed applicant is Wallac Oy, Subsidiary of Perkinelmer. It received FDA 510(k) clearance on 2010-12-16 under 510(k) number K102419. The device is classified under product code JNO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the GSP NEONATAL IRT KIT (3306-001U)?

GSP NEONATAL IRT KIT (3306-001U) is a medical device that received FDA 510(k) clearance on 2010-12-16. The listed applicant is Wallac Oy, Subsidiary of Perkinelmer. The 510(k) number is K102419.

When did GSP NEONATAL IRT KIT (3306-001U) receive FDA 510(k) clearance?

GSP NEONATAL IRT KIT (3306-001U) received FDA 510(k) clearance on 2010-12-16, under 510(k) number K102419.

Who is the listed applicant for GSP NEONATAL IRT KIT (3306-001U)?

The FDA 510(k) record lists Wallac Oy, Subsidiary of Perkinelmer as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GSP NEONATAL IRT KIT (3306-001U)?

The FDA product code for GSP NEONATAL IRT KIT (3306-001U) is JNO.

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Related Devices (Code: JNO)

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.

K110274AUTODELFIA NEONATAL IRT KITWallac Oy, A Subsidiary of Perkinelmer, Inc.K932406NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KITNuclear Diagnostics, Inc.K883011MRI NEO-TRYP TRYPSIN RIAMicrobiological Research Corp.K861097TRYPSIN RIA KITMicroanalytic Research, Inc.K811805TRYPIN (125I) RIA KITBd Becton Dickinson Vacutainer Systems PreanalyticK791202RIA KIT FOR TRYPSINCis Radiopharmaceuticals, 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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