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FDA 510(k)

SPS DISCS

K-Number: K832305 · 1983-08-24

ApplicantOxoid U.S.A., Inc.
Decision Date1983-08-24
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SPS DISCS is the device name listed in this FDA 510(k) record. The listed applicant is Oxoid U.S.A., Inc.. It received FDA 510(k) clearance on 1983-08-24 under 510(k) number K832305. The device is classified under product code JTO. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SPS DISCS?

SPS DISCS is a medical device that received FDA 510(k) clearance on 1983-08-24. The listed applicant is Oxoid U.S.A., Inc.. The 510(k) number is K832305.

When did SPS DISCS receive FDA 510(k) clearance?

SPS DISCS received FDA 510(k) clearance on 1983-08-24, under 510(k) number K832305.

Who is the listed applicant for SPS DISCS?

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

What is the FDA product code for SPS DISCS?

The FDA product code for SPS DISCS is JTO.

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Other records listing Oxoid U.S.A., Inc. as applicant

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Related Devices (Code: JTO)

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.

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLCK970832PYR SWABRemel, Inc.K970834GRAM SWABRemel, Inc.K970833INDOLE SWABRemel, Inc.K970009LYFO(TM) DIFFERENTIAL DISK-BACITRACINMicrobiologics, Inc.K962966IDS RAPID CB PLUS SYSTEMInnovative Diagnostic Systems, Inc.

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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