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FDA 510(k)

FASTPACK HCG IMMUNOASSAY

K-Number: K072264 · 2007-12-06

ApplicantQualigen, Inc.
Decision Date2007-12-06
Product CodeJHI
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FASTPACK HCG IMMUNOASSAY is the device name listed in this FDA 510(k) record. The listed applicant is Qualigen, Inc.. It received FDA 510(k) clearance on 2007-12-06 under 510(k) number K072264. 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 FASTPACK HCG IMMUNOASSAY?

FASTPACK HCG IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2007-12-06. The listed applicant is Qualigen, Inc.. The 510(k) number is K072264.

When did FASTPACK HCG IMMUNOASSAY receive FDA 510(k) clearance?

FASTPACK HCG IMMUNOASSAY received FDA 510(k) clearance on 2007-12-06, under 510(k) number K072264.

Who is the listed applicant for FASTPACK HCG IMMUNOASSAY?

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

What is the FDA product code for FASTPACK HCG IMMUNOASSAY?

The FDA product code for FASTPACK HCG IMMUNOASSAY is JHI.

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Other records listing Qualigen, Inc. as applicant

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K182521FastPack IP Sex Hormone Binding Globulin ImmunoassayK123983FASTPACK VITAMIN D; IMMUNOASSAY, CALIBRATORS, CONTROLS, VERIFIERSK123725FASTPACK CONTROL KITK101388FASTPACK TESTO IMMUNOASSAYK101390FASTPACK TSH IMMUNOASSAYK062957FASTPACK TOTAL PSA METHOD VERIFICATION KIT

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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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