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FDA 510(k)

SAS PREGNANCY STRIP

K-Number: K965253 · 1997-02-18

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

Device Summary

SAS PREGNANCY STRIP 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 K965253. 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 PREGNANCY STRIP?

SAS PREGNANCY STRIP is a medical device that received FDA 510(k) clearance on 1997-02-18. The listed applicant is Sascie. The 510(k) number is K965253.

When did SAS PREGNANCY STRIP receive FDA 510(k) clearance?

SAS PREGNANCY STRIP received FDA 510(k) clearance on 1997-02-18, under 510(k) number K965253.

Who is the listed applicant for SAS PREGNANCY STRIP?

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 PREGNANCY STRIP?

The FDA product code for SAS PREGNANCY STRIP 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.

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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.

K965250SAS SERUM/URINE HCG

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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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