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FDA 510(k)

AUTODELFIA NEONATAL IRT KIT

K-Number: K110274 · 2011-06-10

ApplicantWallac Oy, A Subsidiary of Perkinelmer, Inc.
Decision Date2011-06-10
Product CodeJNO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

AUTODELFIA NEONATAL IRT KIT is the device name listed in this FDA 510(k) record. The listed applicant is Wallac Oy, A Subsidiary of Perkinelmer, Inc.. It received FDA 510(k) clearance on 2011-06-10 under 510(k) number K110274. 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 AUTODELFIA NEONATAL IRT KIT?

AUTODELFIA NEONATAL IRT KIT is a medical device that received FDA 510(k) clearance on 2011-06-10. The listed applicant is Wallac Oy, A Subsidiary of Perkinelmer, Inc.. The 510(k) number is K110274.

When did AUTODELFIA NEONATAL IRT KIT receive FDA 510(k) clearance?

AUTODELFIA NEONATAL IRT KIT received FDA 510(k) clearance on 2011-06-10, under 510(k) number K110274.

Who is the listed applicant for AUTODELFIA NEONATAL IRT KIT?

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

What is the FDA product code for AUTODELFIA NEONATAL IRT KIT?

The FDA product code for AUTODELFIA NEONATAL IRT KIT is JNO.

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Other records listing Wallac Oy, A Subsidiary of Perkinelmer, Inc. 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.

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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.

K102419GSP NEONATAL IRT KIT (3306-001U)Wallac Oy, Subsidiary of PerkinelmerK932406NUCLITRYP(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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