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FDA 510(k)

DART DIGOXIN ASSAY

K-Number: K864802 · 1987-02-12

ApplicantCoulter Electronics, Inc.
Decision Date1987-02-12
Product CodeLCS
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DART DIGOXIN ASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Coulter Electronics, Inc.. It received FDA 510(k) clearance on 1987-02-12 under 510(k) number K864802. The device is classified under product code LCS. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DART DIGOXIN ASSAY?

DART DIGOXIN ASSAY is a medical device that received FDA 510(k) clearance on 1987-02-12. The listed applicant is Coulter Electronics, Inc.. The 510(k) number is K864802.

When did DART DIGOXIN ASSAY receive FDA 510(k) clearance?

DART DIGOXIN ASSAY received FDA 510(k) clearance on 1987-02-12, under 510(k) number K864802.

Who is the listed applicant for DART DIGOXIN ASSAY?

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

What is the FDA product code for DART DIGOXIN ASSAY?

The FDA product code for DART DIGOXIN ASSAY is LCS.

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Other records listing Coulter Electronics, 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.

K923951CD8 CYTOSPHERES KITK930119COULTER RETIC-C CELL CONTROLK921279CD4 CYTOSPHERES KITK923530COULTER MULTI-Q-PREPK922181COULTER MH009K922704COULTER MAXM W/ AUTOLOADER

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Related Devices (Code: LCS)

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.

K922353DIGOXIN COATED TUBE RIAMonobindK913562QMS - DIGOXINSeradyn, Inc.K895828INNOFLUOR DIGOXIN REAGENT SETInnotron of Oregon, Inc.K884707FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KITCyberfluor, Inc.K874748IMMPULSE DIGOXIN ASSAY REAGENTSSclavo, Inc.K820154TDX DIGOXINAbbott Laboratories

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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