FDA 510(k)

SERIM DISINTEK REAGENT STRIPS

K-Number: K913943 · 1992-03-26

Decision Date1992-03-26

Product CodeMED

Advisory CommitteeHO

DecisionSubstantially Equivalent

Device Summary

SERIM DISINTEK REAGENT STRIPS 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 1992-03-26 under 510(k) number K913943. The device is classified under product code MED. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERIM DISINTEK REAGENT STRIPS?

SERIM DISINTEK REAGENT STRIPS is a medical device that received FDA 510(k) clearance on 1992-03-26. The listed applicant is Serim Research Corp.. The 510(k) number is K913943.

When did SERIM DISINTEK REAGENT STRIPS receive FDA 510(k) clearance?

SERIM DISINTEK REAGENT STRIPS received FDA 510(k) clearance on 1992-03-26, under 510(k) number K913943.

Who is the listed applicant for SERIM DISINTEK REAGENT STRIPS?

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 REAGENT STRIPS?

The FDA product code for SERIM DISINTEK REAGENT STRIPS is MED.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.