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FDA 510(k)

ABSOLUTE(TM)-HCG URINE PREGNANCY TEST

K-Number: K893953 · 1989-08-15

ApplicantTotem Diagnostics, Inc.
Decision Date1989-08-15
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ABSOLUTE(TM)-HCG URINE PREGNANCY TEST is the device name listed in this FDA 510(k) record. The listed applicant is Totem Diagnostics, Inc.. It received FDA 510(k) clearance on 1989-08-15 under 510(k) number K893953. 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 ABSOLUTE(TM)-HCG URINE PREGNANCY TEST?

ABSOLUTE(TM)-HCG URINE PREGNANCY TEST is a medical device that received FDA 510(k) clearance on 1989-08-15. The listed applicant is Totem Diagnostics, Inc.. The 510(k) number is K893953.

When did ABSOLUTE(TM)-HCG URINE PREGNANCY TEST receive FDA 510(k) clearance?

ABSOLUTE(TM)-HCG URINE PREGNANCY TEST received FDA 510(k) clearance on 1989-08-15, under 510(k) number K893953.

Who is the listed applicant for ABSOLUTE(TM)-HCG URINE PREGNANCY TEST?

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

What is the FDA product code for ABSOLUTE(TM)-HCG URINE PREGNANCY TEST?

The FDA product code for ABSOLUTE(TM)-HCG URINE PREGNANCY TEST is DHA.

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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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