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FDA 510(k)

OPTIMATE DIGOXIN TEST

K-Number: K853021 · 1985-08-07

ApplicantMiles Laboratories, Inc.
Decision Date1985-08-07
Product CodeDPB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

OPTIMATE DIGOXIN TEST is the device name listed in this FDA 510(k) record. The listed applicant is Miles Laboratories, Inc.. It received FDA 510(k) clearance on 1985-08-07 under 510(k) number K853021. The device is classified under product code DPB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPTIMATE DIGOXIN TEST?

OPTIMATE DIGOXIN TEST is a medical device that received FDA 510(k) clearance on 1985-08-07. The listed applicant is Miles Laboratories, Inc.. The 510(k) number is K853021.

When did OPTIMATE DIGOXIN TEST receive FDA 510(k) clearance?

OPTIMATE DIGOXIN TEST received FDA 510(k) clearance on 1985-08-07, under 510(k) number K853021.

Who is the listed applicant for OPTIMATE DIGOXIN TEST?

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

What is the FDA product code for OPTIMATE DIGOXIN TEST?

The FDA product code for OPTIMATE DIGOXIN TEST is DPB.

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Related Devices (Code: DPB)

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.

K823014DIGOXIN KITPcl-Ria, Inc.K821811125I DIGOXIN RADIOIMMUNOASSAY KITCambridge Medical TechnologyK820274DIGOXIN RADIOIMMUNOASSAYAmerican Diagnostic Corp.K792153DIGOXIN RADIOIMMUNOASSAY SYSTEMRadioimmunoassay, Inc.K790602RIA, DIGNXIN-125-IEndocrine-Metabolic CenterK790540RIA TEST KIT, CENTRIA DIGOXINVentrex Laboratories, 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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