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FDA 510(k)

CREATININE TEST, SUPER SEVENTEEN

K-Number: K770643 · 1977-06-24

ApplicantHycel, Inc.
Decision Date1977-06-24
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE TEST, SUPER SEVENTEEN is the device name listed in this FDA 510(k) record. The listed applicant is Hycel, Inc.. It received FDA 510(k) clearance on 1977-06-24 under 510(k) number K770643. The device is classified under product code CGX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CREATININE TEST, SUPER SEVENTEEN?

CREATININE TEST, SUPER SEVENTEEN is a medical device that received FDA 510(k) clearance on 1977-06-24. The listed applicant is Hycel, Inc.. The 510(k) number is K770643.

When did CREATININE TEST, SUPER SEVENTEEN receive FDA 510(k) clearance?

CREATININE TEST, SUPER SEVENTEEN received FDA 510(k) clearance on 1977-06-24, under 510(k) number K770643.

Who is the listed applicant for CREATININE TEST, SUPER SEVENTEEN?

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 CREATININE TEST, SUPER SEVENTEEN?

The FDA product code for CREATININE TEST, SUPER SEVENTEEN is CGX.

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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: CGX)

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.

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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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