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FDA 510(k)

VICTORCH MEDITEK'S HCG TEST CARD

K-Number: K013678 · 2001-12-27

ApplicantVictorch Meditek, Inc.
Decision Date2001-12-27
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

VICTORCH MEDITEK'S HCG TEST CARD is the device name listed in this FDA 510(k) record. The listed applicant is Victorch Meditek, Inc.. It received FDA 510(k) clearance on 2001-12-27 under 510(k) number K013678. 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 VICTORCH MEDITEK'S HCG TEST CARD?

VICTORCH MEDITEK'S HCG TEST CARD is a medical device that received FDA 510(k) clearance on 2001-12-27. The listed applicant is Victorch Meditek, Inc.. The 510(k) number is K013678.

When did VICTORCH MEDITEK'S HCG TEST CARD receive FDA 510(k) clearance?

VICTORCH MEDITEK'S HCG TEST CARD received FDA 510(k) clearance on 2001-12-27, under 510(k) number K013678.

Who is the listed applicant for VICTORCH MEDITEK'S HCG TEST CARD?

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

What is the FDA product code for VICTORCH MEDITEK'S HCG TEST CARD?

The FDA product code for VICTORCH MEDITEK'S HCG TEST CARD is DHA.

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.

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Other records listing Victorch Meditek, 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.

K013702VICTORCH HCG TEST STRIP

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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