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FDA 510(k)

HCG STAT PAK ULTRA-FAST

K-Number: K011550 · 2001-08-14

ApplicantChembio Diagnostic Systems, Inc.
Decision Date2001-08-14
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HCG STAT PAK ULTRA-FAST is the device name listed in this FDA 510(k) record. The listed applicant is Chembio Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 2001-08-14 under 510(k) number K011550. 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 HCG STAT PAK ULTRA-FAST?

HCG STAT PAK ULTRA-FAST is a medical device that received FDA 510(k) clearance on 2001-08-14. The listed applicant is Chembio Diagnostic Systems, Inc.. The 510(k) number is K011550.

When did HCG STAT PAK ULTRA-FAST receive FDA 510(k) clearance?

HCG STAT PAK ULTRA-FAST received FDA 510(k) clearance on 2001-08-14, under 510(k) number K011550.

Who is the listed applicant for HCG STAT PAK ULTRA-FAST?

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

What is the FDA product code for HCG STAT PAK ULTRA-FAST?

The FDA product code for HCG STAT PAK ULTRA-FAST is JHI.

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Other records listing Chembio Diagnostic Systems, 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.

K011551SURE CHECK PREGNANCY TESTK010244SURE CHECK OVULATION PREDICTORK981913PREVUE(TM) BORRELIA BURGDORFERI ANTIBODY DETECTION ASSAYK961965SURE CHECK PREGNANCY TESTK923925HCG STAT-PAK

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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