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FDA 510(k)

CREATININE URINE APPLI.-#32308

K-Number: K772107 · 1977-11-28

ApplicantHarleco
Decision Date1977-11-28
Product CodeCGX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CREATININE URINE APPLI.-#32308 is the device name listed in this FDA 510(k) record. The listed applicant is Harleco. It received FDA 510(k) clearance on 1977-11-28 under 510(k) number K772107. 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 URINE APPLI.-#32308?

CREATININE URINE APPLI.-#32308 is a medical device that received FDA 510(k) clearance on 1977-11-28. The listed applicant is Harleco. The 510(k) number is K772107.

When did CREATININE URINE APPLI.-#32308 receive FDA 510(k) clearance?

CREATININE URINE APPLI.-#32308 received FDA 510(k) clearance on 1977-11-28, under 510(k) number K772107.

Who is the listed applicant for CREATININE URINE APPLI.-#32308?

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

What is the FDA product code for CREATININE URINE APPLI.-#32308?

The FDA product code for CREATININE URINE APPLI.-#32308 is CGX.

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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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