FDA 510(k)

URI-KIT

K-Number: K850998 · 1985-04-01

Decision Date1985-04-01

Product CodeJSG

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

URI-KIT is the device name listed in this FDA 510(k) record. The listed applicant is Culture Kits, Inc.. It received FDA 510(k) clearance on 1985-04-01 under 510(k) number K850998. The device is classified under product code JSG. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the URI-KIT?

URI-KIT is a medical device that received FDA 510(k) clearance on 1985-04-01. The listed applicant is Culture Kits, Inc.. The 510(k) number is K850998.

When did URI-KIT receive FDA 510(k) clearance?

URI-KIT received FDA 510(k) clearance on 1985-04-01, under 510(k) number K850998.

Who is the listed applicant for URI-KIT?

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

What is the FDA product code for URI-KIT?

The FDA product code for URI-KIT is JSG.

Other records listing Culture Kits, 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.

K911846URI-THREE(TM), MODIFICATION K854672CANDI-KIT TM K853488STAPH KIT K851225URINE DUO K852582GONI-KIT K852480DERM-KIT

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Related Devices (Code: JSG)

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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.