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FDA 510(k)

SINGLE VIAL LIPASE TEST KIT

K-Number: K802842 · 1980-12-18

ApplicantBiodynamics Corp.
Decision Date1980-12-18
Product CodeCHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SINGLE VIAL LIPASE TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Biodynamics Corp.. It received FDA 510(k) clearance on 1980-12-18 under 510(k) number K802842. 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 SINGLE VIAL LIPASE TEST KIT?

SINGLE VIAL LIPASE TEST KIT is a medical device that received FDA 510(k) clearance on 1980-12-18. The listed applicant is Biodynamics Corp.. The 510(k) number is K802842.

When did SINGLE VIAL LIPASE TEST KIT receive FDA 510(k) clearance?

SINGLE VIAL LIPASE TEST KIT received FDA 510(k) clearance on 1980-12-18, under 510(k) number K802842.

Who is the listed applicant for SINGLE VIAL LIPASE TEST KIT?

The FDA 510(k) record lists Biodynamics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SINGLE VIAL LIPASE TEST KIT?

The FDA product code for SINGLE VIAL LIPASE TEST KIT is CHI.

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Other records listing Biodynamics Corp. 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.

K051675BIODYNAMICS BIA 500 BIOMPEDANCE BODY COMPOSITION ANALYZERK884033BIODYNAMICS MODEL 200 BODY COMPOSITION ANALYZERK881631BIODYNAMICS AUTOTRANSFUSION RESERVOIRK881968BIODYNAMICS MODEL BI-400 BODY COMPOSITION ANALYZERK874361BIODYNAMICS MODEL BI-300 BODY COMPOSITION ANALYZERK873807AUTOTRANSFUSION APPARATUS

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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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