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FDA 510(k)

17-HYDROXY TEST

K-Number: K772426 · 1978-01-30

ApplicantHycel, Inc.
Decision Date1978-01-30
Product CodeCDB
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

17-HYDROXY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Hycel, Inc.. It received FDA 510(k) clearance on 1978-01-30 under 510(k) number K772426. The device is classified under product code CDB. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 17-HYDROXY TEST?

17-HYDROXY TEST is a medical device that received FDA 510(k) clearance on 1978-01-30. The listed applicant is Hycel, Inc.. The 510(k) number is K772426.

When did 17-HYDROXY TEST receive FDA 510(k) clearance?

17-HYDROXY TEST received FDA 510(k) clearance on 1978-01-30, under 510(k) number K772426.

Who is the listed applicant for 17-HYDROXY TEST?

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 17-HYDROXY TEST?

The FDA product code for 17-HYDROXY TEST is CDB.

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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 MK782116KETOSTEROID TEST, HYCEL-17K782176HYCEL LDH-INT TESTK782100HYCEL COUNTER 333K782102HYCEL COUNTER 211

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Related Devices (Code: CDB)

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.

K761271URIN. L7-OH CORTICOSTEROID T(NON HYDRO)Eppendorf-Brinkmann, 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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