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FDA 510(k)

FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER

K-Number: K003094 · 2000-10-25

ApplicantQualigen, Inc.
Decision Date2000-10-25
Product CodeLTJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Qualigen, Inc.. It received FDA 510(k) clearance on 2000-10-25 under 510(k) number K003094. The device is classified under product code LTJ. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER?

FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER is a medical device that received FDA 510(k) clearance on 2000-10-25. The listed applicant is Qualigen, Inc.. The 510(k) number is K003094.

When did FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER receive FDA 510(k) clearance?

FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER received FDA 510(k) clearance on 2000-10-25, under 510(k) number K003094.

Who is the listed applicant for FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER?

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 PSA IMMUNOASSAY, FASTPACK ANALYZER?

The FDA product code for FASTPACK PSA IMMUNOASSAY, FASTPACK ANALYZER is LTJ.

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Other records listing Qualigen, 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.

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: LTJ)

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.

K251630Atellica IM Total PSA II (tPSAII)Siemens Healthcare Diagnostics, Inc.K162378FREND PSA PLUS (reagent cartridge)Nanoentek USA, Inc.K124056FREND PSA PLUS (REAGENT CARTRIDGE)Nanoentek, Inc.K031343TPSA FLEX REAGENT CARTRIDGEDade Behring, Inc.K022288COMPLEXED PROSTATE SPECIFIC ANTIGEN (CPSA) ASSAY FOR THE BAYER ADVIA INTEGRATED MODULE SYSTEMBayer Corp.K022177PROSTATE SPECIFIC ANTIGEN (PSA) ASSAY FOR THE ADVIA INTEGRATED MODULAR SYSTEMBayer Diagnostics Corp.

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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