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FDA 510(k)

UROPAPER EIKEN GK

K-Number: K843758 · 1984-12-18

ApplicantSyn-Kit, Inc.
Decision Date1984-12-18
Product CodeJIL
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

UROPAPER EIKEN GK is the device name listed in this FDA 510(k) record. The listed applicant is Syn-Kit, Inc.. It received FDA 510(k) clearance on 1984-12-18 under 510(k) number K843758. 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 UROPAPER EIKEN GK?

UROPAPER EIKEN GK is a medical device that received FDA 510(k) clearance on 1984-12-18. The listed applicant is Syn-Kit, Inc.. The 510(k) number is K843758.

When did UROPAPER EIKEN GK receive FDA 510(k) clearance?

UROPAPER EIKEN GK received FDA 510(k) clearance on 1984-12-18, under 510(k) number K843758.

Who is the listed applicant for UROPAPER EIKEN GK?

The FDA 510(k) record lists Syn-Kit, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for UROPAPER EIKEN GK?

The FDA product code for UROPAPER EIKEN GK is JIL.

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Other records listing Syn-Kit, 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.

K861098SEROIDEN STREPTO KIT 'EIKEN'K861631SLIDE CULTURE U 'EIKEN'K854819CPR SLIDE EIKENK854820RA 80 EIKENK853276ASO SLIDE EIKENK843753UROPAPER EIKEN GP

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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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