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FDA 510(k)

RAPICIDE OPA-28 TEST STRIP

K-Number: K120652 · 2012-10-12

ApplicantSerim Research Corp.
Decision Date2012-10-12
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

RAPICIDE OPA-28 TEST STRIP 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 2012-10-12 under 510(k) number K120652. 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 RAPICIDE OPA-28 TEST STRIP?

RAPICIDE OPA-28 TEST STRIP is a medical device that received FDA 510(k) clearance on 2012-10-12. The listed applicant is Serim Research Corp.. The 510(k) number is K120652.

When did RAPICIDE OPA-28 TEST STRIP receive FDA 510(k) clearance?

RAPICIDE OPA-28 TEST STRIP received FDA 510(k) clearance on 2012-10-12, under 510(k) number K120652.

Who is the listed applicant for RAPICIDE OPA-28 TEST STRIP?

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 RAPICIDE OPA-28 TEST STRIP?

The FDA product code for RAPICIDE OPA-28 TEST STRIP is JOJ.

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Other records listing Serim Research Corp. as applicant

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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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