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FDA 510(k)

ACCESS TOTAL BHCG (5TH IS)

K-Number: K130020 · 2013-10-01

ApplicantBeckman Coulter, Inc.
Decision Date2013-10-01
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCESS TOTAL BHCG (5TH IS) is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2013-10-01 under 510(k) number K130020. The device is classified under product code DHA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCESS TOTAL BHCG (5TH IS)?

ACCESS TOTAL BHCG (5TH IS) is a medical device that received FDA 510(k) clearance on 2013-10-01. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K130020.

When did ACCESS TOTAL BHCG (5TH IS) receive FDA 510(k) clearance?

ACCESS TOTAL BHCG (5TH IS) received FDA 510(k) clearance on 2013-10-01, under 510(k) number K130020.

Who is the listed applicant for ACCESS TOTAL BHCG (5TH IS)?

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

What is the FDA product code for ACCESS TOTAL BHCG (5TH IS)?

The FDA product code for ACCESS TOTAL BHCG (5TH IS) is DHA.

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Other records listing Beckman Coulter, Inc. as applicant

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Related Devices (Code: DHA)

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.

K233581VITROS Immunodiagnostic Products Total ß-hCG II Reagent PackOrtho Clinical DiagnosticsK223690iFlash-HCG; Chemiluminescence Immunoassay Analyzer (Model: iFlash 3000-C)Shenzhen Yhlo Biotech Co., Ltd.K230937Alinity i Total ß-hCG Reagent Kit, GLP systems TrackAbbott LaboratoriesK230790Alinity i Total B-hCG Reagent Kit, Alinity c Glucose Reagent Kit, Alinity c ICT Sample Diluent, Alinity ci-seriesAbbott LaboratoriesK221990Access Total ßhCG (5th IS)Beckman Coulter, Inc.K212221Diazyme DZ-Lite iFlash Total beta-hCG Assay, Diazyme DZ-Lite iFlash 1800 Chemiluminescence Immunoassay AnalyzerDiazyme 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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