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FDA 510(k)

SAS(TM) SERUM/URINE HCG

K-Number: K932409 · 1993-06-29

ApplicantSa Scientific, Inc.
Decision Date1993-06-29
Product CodeDHA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SAS(TM) SERUM/URINE HCG is the device name listed in this FDA 510(k) record. The listed applicant is Sa Scientific, Inc.. It received FDA 510(k) clearance on 1993-06-29 under 510(k) number K932409. 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 SAS(TM) SERUM/URINE HCG?

SAS(TM) SERUM/URINE HCG is a medical device that received FDA 510(k) clearance on 1993-06-29. The listed applicant is Sa Scientific, Inc.. The 510(k) number is K932409.

When did SAS(TM) SERUM/URINE HCG receive FDA 510(k) clearance?

SAS(TM) SERUM/URINE HCG received FDA 510(k) clearance on 1993-06-29, under 510(k) number K932409.

Who is the listed applicant for SAS(TM) SERUM/URINE HCG?

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

What is the FDA product code for SAS(TM) SERUM/URINE HCG?

The FDA product code for SAS(TM) SERUM/URINE HCG is DHA.

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Other records listing Sa Scientific, 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.

K100227SAS FLUALERT A&B, SAS INFLUENZA A TESTK080380SAS INFLUENZA A & B TESTK041439SAS INFLUENZA B TESTK041441SAS INFLUENZA A TESTK030628SAS RSV CONTROL KITK022845SAS RSV TEST

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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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