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FDA 510(k)

SUPERSERUM REAGENT (SSR)

K-Number: K910646 · 1991-05-10

ApplicantInternational Technidyne Corp.
Decision Date1991-05-10
Product CodeJKA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SUPERSERUM REAGENT (SSR) is the device name listed in this FDA 510(k) record. The listed applicant is International Technidyne Corp.. It received FDA 510(k) clearance on 1991-05-10 under 510(k) number K910646. The device is classified under product code JKA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUPERSERUM REAGENT (SSR)?

SUPERSERUM REAGENT (SSR) is a medical device that received FDA 510(k) clearance on 1991-05-10. The listed applicant is International Technidyne Corp.. The 510(k) number is K910646.

When did SUPERSERUM REAGENT (SSR) receive FDA 510(k) clearance?

SUPERSERUM REAGENT (SSR) received FDA 510(k) clearance on 1991-05-10, under 510(k) number K910646.

Who is the listed applicant for SUPERSERUM REAGENT (SSR)?

The FDA 510(k) record lists International Technidyne Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SUPERSERUM REAGENT (SSR)?

The FDA product code for SUPERSERUM REAGENT (SSR) is JKA.

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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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