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FDA 510(k)

YD STRIP GPH U21

K-Number: K834387 · 1984-05-14

ApplicantYd Pharmaceutical Corp.
Decision Date1984-05-14
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

YD STRIP GPH U21 is the device name listed in this FDA 510(k) record. The listed applicant is Yd Pharmaceutical Corp.. It received FDA 510(k) clearance on 1984-05-14 under 510(k) number K834387. The device is classified under product code JIL. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the YD STRIP GPH U21?

YD STRIP GPH U21 is a medical device that received FDA 510(k) clearance on 1984-05-14. The listed applicant is Yd Pharmaceutical Corp.. The 510(k) number is K834387.

When did YD STRIP GPH U21 receive FDA 510(k) clearance?

YD STRIP GPH U21 received FDA 510(k) clearance on 1984-05-14, under 510(k) number K834387.

Who is the listed applicant for YD STRIP GPH U21?

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

What is the FDA product code for YD STRIP GPH U21?

The FDA product code for YD STRIP GPH U21 is JIL.

Related Clinical Trials

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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Other records listing Yd Pharmaceutical Corp. 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.

K834386YD STRIP GP U20K834385YD STRIP GLUCOSE U19

Related Devices (Code: JIL)

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.

K193514AUTION MAX AX-4060 Urinalysis SystemArkray, Inc.K183432cobas u 601 urinalysis test systemRoche DiagnosticsK173327DIP/U.S. Urine Analysis Test SystemHealthy.Io, Ltd.K180356inui In-Home Urine Analysis Test SystemScanadu, Inc.K181024DUS 2GP Reagent Strips, DUS 5 Reagent Strips, DUS 10 Reagent StripsDFI Co., Ltd.K171521DUS R-50S (Urine Chemistry system)DFI Co., Ltd.

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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