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FDA 510(k)

ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY

K-Number: K923917 · 1994-02-25

ApplicantNuclear Diagnostics, Inc.
Decision Date1994-02-25
Product CodeCHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY 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 1994-02-25 under 510(k) number K923917. The device is classified under product code CHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY?

ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY is a medical device that received FDA 510(k) clearance on 1994-02-25. The listed applicant is Nuclear Diagnostics, Inc.. The 510(k) number is K923917.

When did ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY receive FDA 510(k) clearance?

ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY received FDA 510(k) clearance on 1994-02-25, under 510(k) number K923917.

Who is the listed applicant for ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY?

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 ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY?

The FDA product code for ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAY is CHI.

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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.

K932406NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KITK872177TIPSEP-CORTISOL RIA DIAGNOSTIC KITK862312ENZLIPASE, ENZYMATIC LIPASE KITK860472NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESSK861735TIPSEP-TBG ASSAYK852291TIPSEP DIGOXIN RIA

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Related Devices (Code: CHI)

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.

K970905SYNCHRON CX SYSTEMS LIPASE (LIPA) REAGENTBeckman Instruments, Inc.K961179SENTINEL LIPASE LIQUID MODEL 17.401BEqual Diagnostics, Inc.K952180CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMSBeckman Instruments, Inc.K952647IL TEST LIPASEInstrumentation Laboratory COK952816LIPASE FLEX REAGENT CARTRIDGEDupont Medical ProductsK941085LIPASE-PS ASSAY PROCEDURE NO. 805Sigma Diagnostics, 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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