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FDA 510(k)

SPOROX TEST STRIPS

K-Number: K972035 · 1997-08-29

ApplicantSerim Research Corp.
Decision Date1997-08-29
Product CodeJOJ
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SPOROX TEST 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 1997-08-29 under 510(k) number K972035. 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 SPOROX TEST STRIPS?

SPOROX TEST STRIPS is a medical device that received FDA 510(k) clearance on 1997-08-29. The listed applicant is Serim Research Corp.. The 510(k) number is K972035.

When did SPOROX TEST STRIPS receive FDA 510(k) clearance?

SPOROX TEST STRIPS received FDA 510(k) clearance on 1997-08-29, under 510(k) number K972035.

Who is the listed applicant for SPOROX TEST 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 SPOROX TEST STRIPS?

The FDA product code for SPOROX TEST STRIPS is JOJ.

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Other records listing Serim Research Corp. as applicant

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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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