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FDA 510(k)

NUCLIPASE (I125) PANCREATIC LIPASE

K-Number: K823860 · 1983-04-18

ApplicantNuclear Diagnostics, Inc.
Decision Date1983-04-18
Product CodeCET
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

NUCLIPASE (I125) PANCREATIC LIPASE is the device name listed in this FDA 510(k) record. The listed applicant is Nuclear Diagnostics, Inc.. It received FDA 510(k) clearance on 1983-04-18 under 510(k) number K823860. The device is classified under product code CET. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NUCLIPASE (I125) PANCREATIC LIPASE?

NUCLIPASE (I125) PANCREATIC LIPASE is a medical device that received FDA 510(k) clearance on 1983-04-18. The listed applicant is Nuclear Diagnostics, Inc.. The 510(k) number is K823860.

When did NUCLIPASE (I125) PANCREATIC LIPASE receive FDA 510(k) clearance?

NUCLIPASE (I125) PANCREATIC LIPASE received FDA 510(k) clearance on 1983-04-18, under 510(k) number K823860.

Who is the listed applicant for NUCLIPASE (I125) PANCREATIC LIPASE?

The FDA 510(k) record lists Nuclear Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NUCLIPASE (I125) PANCREATIC LIPASE?

The FDA product code for NUCLIPASE (I125) PANCREATIC LIPASE is CET.

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Other records listing Nuclear Diagnostics, 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.

K923917ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAYK932406NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KITK872177TIPSEP-CORTISOL RIA DIAGNOSTIC KITK862312ENZLIPASE, ENZYMATIC LIPASE KITK860472NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESSK861735TIPSEP-TBG ASSAY

View all 22 devices →

Related Devices (Code: CET)

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.

K970124LIPASE REAGENT SET (COLIPASE METHOD)Teco DiagnosticsK940457LIPASE REAGENT SYSTEMMedical Diagnostic Technologies, Inc.K915706LIPASE REAGENT SETTech Intl. Co.K901858MODIFIED LABELING FOR ACA LIPASE ANALYTICAL TESTE.I. Dupont DE Nemours & Co., Inc.K893718DELTATEST (R) LIPASE IIElectro-Nucleonics, Inc.K885078LIPASE SR LIQUID STABLE REAGENT SETMedical Analysis Systems, 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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