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FDA 510(k)

FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM

K-Number: K994419 · 2000-06-28

ApplicantQualisys Diagnostics, Inc.
Decision Date2000-06-28
Product CodeLTJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Qualisys Diagnostics, Inc.. It received FDA 510(k) clearance on 2000-06-28 under 510(k) number K994419. 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 SYSTEM?

FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM is a medical device that received FDA 510(k) clearance on 2000-06-28. The listed applicant is Qualisys Diagnostics, Inc.. The 510(k) number is K994419.

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

FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM received FDA 510(k) clearance on 2000-06-28, under 510(k) number K994419.

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

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

What is the FDA product code for FASTPACK PSA IMMUNOASSAY, FASTPACK SYSTEM?

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

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 Qualisys Diagnostics, 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.

K990234QUALISYS PSA IMMUNOASSAY

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

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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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