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FDA 510(k)

SENTINEL LIPASE LIQUID MODEL 17.401B

K-Number: K961179 · 1996-07-19

ApplicantEqual Diagnostics, Inc.
Decision Date1996-07-19
Product CodeCHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SENTINEL LIPASE LIQUID MODEL 17.401B is the device name listed in this FDA 510(k) record. The listed applicant is Equal Diagnostics, Inc.. It received FDA 510(k) clearance on 1996-07-19 under 510(k) number K961179. 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 SENTINEL LIPASE LIQUID MODEL 17.401B?

SENTINEL LIPASE LIQUID MODEL 17.401B is a medical device that received FDA 510(k) clearance on 1996-07-19. The listed applicant is Equal Diagnostics, Inc.. The 510(k) number is K961179.

When did SENTINEL LIPASE LIQUID MODEL 17.401B receive FDA 510(k) clearance?

SENTINEL LIPASE LIQUID MODEL 17.401B received FDA 510(k) clearance on 1996-07-19, under 510(k) number K961179.

Who is the listed applicant for SENTINEL LIPASE LIQUID MODEL 17.401B?

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

What is the FDA product code for SENTINEL LIPASE LIQUID MODEL 17.401B?

The FDA product code for SENTINEL LIPASE LIQUID MODEL 17.401B is CHI.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Equal 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.

K981800SENTINEL CHOLINESTERASE LIQUID MODEL NUMBER 17.019A & 17.606

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.K952180CX LIPASE REAGENT & CALIBRATOR FOR SYNCHRON CX SYSTEMSBeckman Instruments, Inc.K952816LIPASE FLEX REAGENT CARTRIDGEDupont Medical ProductsK952647IL TEST LIPASEInstrumentation Laboratory COK941085LIPASE-PS ASSAY PROCEDURE NO. 805Sigma Diagnostics, Inc.K923917ELIPASE HUMAN PANCREATIC LIPASE ENZYMEIMMUNOASSAYNuclear Diagnostics, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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