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FDA 510(k)

SERIM DISINTEK OPA TEST STRIP

K-Number: K082352 · 2008-09-25

ApplicantSerim Research Corp.
Decision Date2008-09-25
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SERIM DISINTEK OPA 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 2008-09-25 under 510(k) number K082352. 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 DISINTEK OPA TEST STRIP?

SERIM DISINTEK OPA TEST STRIP is a medical device that received FDA 510(k) clearance on 2008-09-25. The listed applicant is Serim Research Corp.. The 510(k) number is K082352.

When did SERIM DISINTEK OPA TEST STRIP receive FDA 510(k) clearance?

SERIM DISINTEK OPA TEST STRIP received FDA 510(k) clearance on 2008-09-25, under 510(k) number K082352.

Who is the listed applicant for SERIM DISINTEK OPA 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 SERIM DISINTEK OPA TEST STRIP?

The FDA product code for SERIM DISINTEK OPA TEST STRIP is JOJ.

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Other records listing Serim Research Corp. as applicant

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K120652RAPICIDE OPA-28 TEST STRIPK092346SERIM D-CIDE GTA 1.5% TEST STRIP, MODEL PART NUMBER 5171K083295SERIM DISINTEK GTA 2.1%, MODEL: 5164K081370SERIM DISINTEK OPA TEST STRIPK080712SERIM HISENSE ULTRA 0.1, PART NUMBER 5167K052388SERIM PERACETIC ACID CHEMICAL INDICATOR

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Related Devices (Code: 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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