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FDA 510(k)

HYCEL M

K-Number: K790335 · 1979-02-27

ApplicantHycel, Inc.
Decision Date1979-02-27
Product CodeJJF
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HYCEL M is the device name listed in this FDA 510(k) record. The listed applicant is Hycel, Inc.. It received FDA 510(k) clearance on 1979-02-27 under 510(k) number K790335. The device is classified under product code JJF. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HYCEL M?

HYCEL M is a medical device that received FDA 510(k) clearance on 1979-02-27. The listed applicant is Hycel, Inc.. The 510(k) number is K790335.

When did HYCEL M receive FDA 510(k) clearance?

HYCEL M received FDA 510(k) clearance on 1979-02-27, under 510(k) number K790335.

Who is the listed applicant for HYCEL M?

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

What is the FDA product code for HYCEL M?

The FDA product code for HYCEL M is JJF.

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Other records listing Hycel, 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.

K802422HYCEL TRIGYCERIDE II TESTK782176HYCEL LDH-INT TESTK782116KETOSTEROID TEST, HYCEL-17K782101HYCEL COUNTER 222K782102HYCEL COUNTER 211K782100HYCEL COUNTER 333

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Related Devices (Code: JJF)

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.

K052794ETI-MAX 3000DiaSorin, Inc.K040332POLYMEDCO SPOTCHEM EZ CHEMISTRY ANALYZERArkray, Inc.K033734LIGHTCYCLER INSTRUMENT VERSION 1.2Roche Diagnostics Corp.K013654PRECISION SYSTEMS ANALETTE CHEMISTRY ANALYZERPrecision Systems, Inc.K012966ROCHE COBAS TAQMAN ANALYZERRoche Molecular Systems, Inc.K993634CARESIDE ANALYZERCareside, 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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