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FDA 510(k)

UROPAPER EIKEN GP

K-Number: K843753 · 1984-12-18

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

Device Summary

UROPAPER EIKEN GP 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 K843753. 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 GP?

UROPAPER EIKEN GP 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 K843753.

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

UROPAPER EIKEN GP received FDA 510(k) clearance on 1984-12-18, under 510(k) number K843753.

Who is the listed applicant for UROPAPER EIKEN GP?

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 GP?

The FDA product code for UROPAPER EIKEN GP 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 EIKENK843758UROPAPER EIKEN GK

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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.

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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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