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FDA 510(k)

SAS SERUM/URINE HCG

K-Number: K965250 · 1997-02-18

ApplicantSascie
Decision Date1997-02-18
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

SAS SERUM/URINE HCG is the device name listed in this FDA 510(k) record. The listed applicant is Sascie. It received FDA 510(k) clearance on 1997-02-18 under 510(k) number K965250. The device is classified under product code JHI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SAS SERUM/URINE HCG?

SAS SERUM/URINE HCG is a medical device that received FDA 510(k) clearance on 1997-02-18. The listed applicant is Sascie. The 510(k) number is K965250.

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

SAS SERUM/URINE HCG received FDA 510(k) clearance on 1997-02-18, under 510(k) number K965250.

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

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

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

The FDA product code for SAS SERUM/URINE HCG is JHI.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Sascie 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.

K965253SAS PREGNANCY STRIP

Related Devices (Code: JHI)

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.

K262299Instant-View® hCG Combo II Cassette TestAlfa Scientific Designs, Inc.K241919Innovita HCG Pregnancy Rapid Combo TestInnovita (Tangshan) Biological Technology Co., Ltd.K203272Alltest Pregnancy Rapid Combo Test CassetteHangzhou AllTest Biotech Co., Ltd.K172322Atellica IM Total hCG (ThCG)Siemens Healthcare Diagnostics, Inc.K172257TrueDX hCG Early Result Pregnancy Test (Midstream Format), TrueDX hCG Early Result Pregnancy Test (Cassette Format), VeriClear Early Result Pregnancy Test (Midstream Format), VeriClear Early Result Pregnancy Test (Cassette Format)True Diagnostics, Inc.K152768Assure Tech hCG Pregnancy Serum/Urine Combo Test Cassette, Assure Tech hCG Pregnancy Serum/Urine Combo Test StripAssure Tech. Co., Ltd.

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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