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FDA 510(k)

KETOSTEROID TEST, HYCEL-17

K-Number: K782116 · 1979-01-26

ApplicantHycel, Inc.
Decision Date1979-01-26
Product CodeCCY
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

KETOSTEROID TEST, HYCEL-17 is the device name listed in this FDA 510(k) record. The listed applicant is Hycel, Inc.. It received FDA 510(k) clearance on 1979-01-26 under 510(k) number K782116. The device is classified under product code CCY. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the KETOSTEROID TEST, HYCEL-17?

KETOSTEROID TEST, HYCEL-17 is a medical device that received FDA 510(k) clearance on 1979-01-26. The listed applicant is Hycel, Inc.. The 510(k) number is K782116.

When did KETOSTEROID TEST, HYCEL-17 receive FDA 510(k) clearance?

KETOSTEROID TEST, HYCEL-17 received FDA 510(k) clearance on 1979-01-26, under 510(k) number K782116.

Who is the listed applicant for KETOSTEROID TEST, HYCEL-17?

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 KETOSTEROID TEST, HYCEL-17?

The FDA product code for KETOSTEROID TEST, HYCEL-17 is CCY.

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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 TESTK790335HYCEL MK782176HYCEL LDH-INT TESTK782101HYCEL COUNTER 222K782102HYCEL COUNTER 211K782100HYCEL COUNTER 333

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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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