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FDA 510(k)

ENZLIPASE, ENZYMATIC LIPASE KIT

K-Number: K862312 · 1986-09-26

ApplicantNuclear Diagnostics, Inc.
Decision Date1986-09-26
Product CodeCHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ENZLIPASE, ENZYMATIC LIPASE KIT 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 1986-09-26 under 510(k) number K862312. 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 ENZLIPASE, ENZYMATIC LIPASE KIT?

ENZLIPASE, ENZYMATIC LIPASE KIT is a medical device that received FDA 510(k) clearance on 1986-09-26. The listed applicant is Nuclear Diagnostics, Inc.. The 510(k) number is K862312.

When did ENZLIPASE, ENZYMATIC LIPASE KIT receive FDA 510(k) clearance?

ENZLIPASE, ENZYMATIC LIPASE KIT received FDA 510(k) clearance on 1986-09-26, under 510(k) number K862312.

Who is the listed applicant for ENZLIPASE, ENZYMATIC LIPASE KIT?

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 ENZLIPASE, ENZYMATIC LIPASE KIT?

The FDA product code for ENZLIPASE, ENZYMATIC LIPASE KIT 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.

K923917ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAYK932406NUCLITRYP(TM)(I125)-HUMAN PANCREA CATH TRY RAD KITK872177TIPSEP-CORTISOL RIA DIAGNOSTIC KITK860472NUCLEAR LASER ALIGNMENT SYSTEM FOR CARDIC STRESSK861735TIPSEP-TBG ASSAYK852291TIPSEP DIGOXIN RIA

View all 22 devices →

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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