Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SPOTTEST DMACA INDOLE REAGENT

K-Number: K840576 · 1984-02-27

ApplicantDifco Laboratories, Inc.
Decision Date1984-02-27
Product CodeJTO
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SPOTTEST DMACA INDOLE REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Difco Laboratories, Inc.. It received FDA 510(k) clearance on 1984-02-27 under 510(k) number K840576. 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 SPOTTEST DMACA INDOLE REAGENT?

SPOTTEST DMACA INDOLE REAGENT is a medical device that received FDA 510(k) clearance on 1984-02-27. The listed applicant is Difco Laboratories, Inc.. The 510(k) number is K840576.

When did SPOTTEST DMACA INDOLE REAGENT receive FDA 510(k) clearance?

SPOTTEST DMACA INDOLE REAGENT received FDA 510(k) clearance on 1984-02-27, under 510(k) number K840576.

Who is the listed applicant for SPOTTEST DMACA INDOLE REAGENT?

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

What is the FDA product code for SPOTTEST DMACA INDOLE REAGENT?

The FDA product code for SPOTTEST DMACA INDOLE REAGENT 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 Difco 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.

K971120DISPENS-O-DISC (TM) LEVOFLOXACINK971211DISPENS-O-DISC SPARFLOXACINK963508DISPENS-O-DISC MEROPENEMK961148CEFEPIME DISPANS-O-DISC (CEFEPLIME - 30MCG)K954783DRYSLIDE CARTARRHALISK954784DRYSIDE NEISSERIA

View all 121 devices →

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.

↑