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FDA 510(k)

STA-LIATEST D-DI TEST KIT

K-Number: K964728 · 1997-06-26

ApplicantAmerican Bioproducts Co.
Decision Date1997-06-26
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STA-LIATEST D-DI TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is American Bioproducts Co.. It received FDA 510(k) clearance on 1997-06-26 under 510(k) number K964728. The device is classified under product code DAP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the STA-LIATEST D-DI TEST KIT?

STA-LIATEST D-DI TEST KIT is a medical device that received FDA 510(k) clearance on 1997-06-26. The listed applicant is American Bioproducts Co.. The 510(k) number is K964728.

When did STA-LIATEST D-DI TEST KIT receive FDA 510(k) clearance?

STA-LIATEST D-DI TEST KIT received FDA 510(k) clearance on 1997-06-26, under 510(k) number K964728.

Who is the listed applicant for STA-LIATEST D-DI TEST KIT?

The FDA 510(k) record lists American Bioproducts Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STA-LIATEST D-DI TEST KIT?

The FDA product code for STA-LIATEST D-DI TEST KIT is DAP.

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Other records listing American Bioproducts Co. 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.

K983460STAR AUTOMATED MULTI-PARAMETRIC ANALYZERK971519ASSERACHROM TPA TEST KITK964716STA LIATEST CONTROL [N]+[P] KITK964718STA D-DI CALIBRATOR KITK962675STA - LIATEST VWF TEST KITK962671STA-VWF CALIBRATOR KIT

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Related Devices (Code: DAP)

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.

K253985INNOVANCE® D-Dimer 2.0 (SMN 10873803)Siemens Healthcare Diagnostic Products GmbHK172903HemosIL D-Dimer HS 500Instrumentation Laboratory COK162227STA® - Liatest® D-DiDiagnostica StagoK160885HemosIL D-Dimer HSInstrumentation Laboratory COK112818VIDAS D-DIMER EXCLUSION II (DEX2)bioMerieux, Inc.K110303STRATUS CS ACUTE CARE D-DIMERSiemens Healthcare Diagnostics

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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