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FDA 510(k)

SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171

K-Number: K092346 · 2010-01-07

ApplicantSerim Research Corp.
Decision Date2010-01-07
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 is the device name listed in this FDA 510(k) record. The listed applicant is Serim Research Corp.. It received FDA 510(k) clearance on 2010-01-07 under 510(k) number K092346. The device is classified under product code JOJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171?

SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 is a medical device that received FDA 510(k) clearance on 2010-01-07. The listed applicant is Serim Research Corp.. The 510(k) number is K092346.

When did SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 receive FDA 510(k) clearance?

SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 received FDA 510(k) clearance on 2010-01-07, under 510(k) number K092346.

Who is the listed applicant for SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171?

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

What is the FDA product code for SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171?

The FDA product code for SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171 is JOJ.

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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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