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FDA 510(k)

FASTPACK FREE T4 IMMUNOASSAY

K-Number: K030329 · 2003-07-03

ApplicantQualigen, Inc.
Decision Date2003-07-03
Product CodeCEC
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

FASTPACK FREE T4 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 2003-07-03 under 510(k) number K030329. The device is classified under product code CEC. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FASTPACK FREE T4 IMMUNOASSAY?

FASTPACK FREE T4 IMMUNOASSAY is a medical device that received FDA 510(k) clearance on 2003-07-03. The listed applicant is Qualigen, Inc.. The 510(k) number is K030329.

When did FASTPACK FREE T4 IMMUNOASSAY receive FDA 510(k) clearance?

FASTPACK FREE T4 IMMUNOASSAY received FDA 510(k) clearance on 2003-07-03, under 510(k) number K030329.

Who is the listed applicant for FASTPACK FREE T4 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 FREE T4 IMMUNOASSAY?

The FDA product code for FASTPACK FREE T4 IMMUNOASSAY is CEC.

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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 IMMUNOASSAYK072264FASTPACK HCG IMMUNOASSAY

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Related Devices (Code: CEC)

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.

K240273Access Free T4Beckman Coulter, Inc.K220456Elecsys FT4 IVRoche DiagnosticsK182423MAGLUMI 2000 FT4Shenzhen New Industries Biomedical Engineering Co., Ltd.K181233Elecsys FT4 IIIRoche DiagnosticsK173122Abbott Architect Free T4Abbott LaboratoriesK152422FREND™ Free T4 Test SystemNanoentek USA, 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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