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FDA 510(k)

IN VITRO DIAGNOSTIC STANDARDS

K-Number: K802278 · 1980-11-24

ApplicantSupelco, Inc.
Decision Date1980-11-24
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

IN VITRO DIAGNOSTIC STANDARDS is the device name listed in this FDA 510(k) record. The listed applicant is Supelco, Inc.. It received FDA 510(k) clearance on 1980-11-24 under 510(k) number K802278. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IN VITRO DIAGNOSTIC STANDARDS?

IN VITRO DIAGNOSTIC STANDARDS is a medical device that received FDA 510(k) clearance on 1980-11-24. The listed applicant is Supelco, Inc.. The 510(k) number is K802278.

When did IN VITRO DIAGNOSTIC STANDARDS receive FDA 510(k) clearance?

IN VITRO DIAGNOSTIC STANDARDS received FDA 510(k) clearance on 1980-11-24, under 510(k) number K802278.

Who is the listed applicant for IN VITRO DIAGNOSTIC STANDARDS?

The FDA 510(k) record lists Supelco, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IN VITRO DIAGNOSTIC STANDARDS?

The FDA product code for IN VITRO DIAGNOSTIC STANDARDS is DIF.

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Other records listing Supelco, Inc. as applicant

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K894141LIQUID CHROMATOGRAPHY COLUMNSK884403LIQUID CHROMATOGRAPHY COLUMNS SOLID PHASE EX. TUBEK883615LIQUID CHROMATOGRAPHY COLUMNS 5-7070/71/72/73K881868LIQUID CHROMATOGRAPHY COLUMNS HISEP COLUMN & GUARDK881361SOLID PHASE EXTRACTION TUBESK880724LIQUID CHROMATO. COLUMNS

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Related Devices (Code: DIF)

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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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