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FDA 510(k)

RAPID SST

K-Number: K821040 · 1982-05-03

ApplicantMds Laboratories, Inc.
Decision Date1982-05-03
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

RAPID SST is the device name listed in this FDA 510(k) record. The listed applicant is Mds Laboratories, Inc.. It received FDA 510(k) clearance on 1982-05-03 under 510(k) number K821040. 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 RAPID SST?

RAPID SST is a medical device that received FDA 510(k) clearance on 1982-05-03. The listed applicant is Mds Laboratories, Inc.. The 510(k) number is K821040.

When did RAPID SST receive FDA 510(k) clearance?

RAPID SST received FDA 510(k) clearance on 1982-05-03, under 510(k) number K821040.

Who is the listed applicant for RAPID SST?

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

What is the FDA product code for RAPID SST?

The FDA product code for RAPID SST is JTO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Mds Laboratories, Inc. 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.

K864242HEKTOEN ENTERIC AGARK864252THAYER-MARTIN JEMBECK864247MUELLER HINTON AGAR WITH 5% SHEEP BLOODK864244GARNERELLA VAGINALIS IDENTIFICATION KITK864249NORMAL SALINE STERILEK864241DNASE AGAR

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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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