FDA 510(k)

SPS DISK

K-Number: K812084 · 1981-08-13

Decision Date1981-08-13

Product CodeJTO

Advisory CommitteeMI

DecisionSubstantially Equivalent

Device Summary

SPS DISK is the device name listed in this FDA 510(k) record. The listed applicant is Remel Co.. It received FDA 510(k) clearance on 1981-08-13 under 510(k) number K812084. 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 DISK?

SPS DISK is a medical device that received FDA 510(k) clearance on 1981-08-13. The listed applicant is Remel Co.. The 510(k) number is K812084.

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

SPS DISK received FDA 510(k) clearance on 1981-08-13, under 510(k) number K812084.

Who is the listed applicant for SPS DISK?

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

What is the FDA product code for SPS DISK?

The FDA product code for SPS DISK is JTO.

Other records listing Remel Co. 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.

K013711BACTI-SWAB DRY K965151A.C.T. III K965150A.C.T. IV K965152A.C.T. II K965149A.C.T. I K960090CALCOFLUOR WHITE STAIN KIT

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Related Devices (Code: JTO)

K050352IN-VITRO DIAGNOSTIC VAGINITIS TEST KITAmeritek Research, LLC K970832PYR 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.