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FDA 510(k)

ACTIVE PSA ELISA (DSL-10-9700)

K-Number: K973243 · 1998-08-03

ApplicantDiagnostic Systems Laboratories, Inc.
Decision Date1998-08-03
Product CodeLTJ
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ACTIVE PSA ELISA (DSL-10-9700) is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Systems Laboratories, Inc.. It received FDA 510(k) clearance on 1998-08-03 under 510(k) number K973243. 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 ACTIVE PSA ELISA (DSL-10-9700)?

ACTIVE PSA ELISA (DSL-10-9700) is a medical device that received FDA 510(k) clearance on 1998-08-03. The listed applicant is Diagnostic Systems Laboratories, Inc.. The 510(k) number is K973243.

When did ACTIVE PSA ELISA (DSL-10-9700) receive FDA 510(k) clearance?

ACTIVE PSA ELISA (DSL-10-9700) received FDA 510(k) clearance on 1998-08-03, under 510(k) number K973243.

Who is the listed applicant for ACTIVE PSA ELISA (DSL-10-9700)?

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

What is the FDA product code for ACTIVE PSA ELISA (DSL-10-9700)?

The FDA product code for ACTIVE PSA ELISA (DSL-10-9700) is LTJ.

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Other records listing Diagnostic Systems Laboratories, Inc. as applicant

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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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