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FDA 510(k)

SERIM HISENSE TEST KIT

K-Number: K952215 · 1995-08-09

ApplicantSerim Research Corp.
Decision Date1995-08-09
Product CodeFIP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

SERIM HISENSE TEST KIT 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 1995-08-09 under 510(k) number K952215. The device is classified under product code FIP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SERIM HISENSE TEST KIT?

SERIM HISENSE TEST KIT is a medical device that received FDA 510(k) clearance on 1995-08-09. The listed applicant is Serim Research Corp.. The 510(k) number is K952215.

When did SERIM HISENSE TEST KIT receive FDA 510(k) clearance?

SERIM HISENSE TEST KIT received FDA 510(k) clearance on 1995-08-09, under 510(k) number K952215.

Who is the listed applicant for SERIM HISENSE TEST KIT?

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 HISENSE TEST KIT?

The FDA product code for SERIM HISENSE TEST KIT is FIP.

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Other records listing Serim Research Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: FIP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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