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FDA 510(k)

FDP PLASMA TEST KIT

K-Number: K920943 · 1992-07-13

ApplicantAmerican Bioproducts Co.
Decision Date1992-07-13
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FDP PLASMA 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 1992-07-13 under 510(k) number K920943. 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 FDP PLASMA TEST KIT?

FDP PLASMA TEST KIT is a medical device that received FDA 510(k) clearance on 1992-07-13. The listed applicant is American Bioproducts Co.. The 510(k) number is K920943.

When did FDP PLASMA TEST KIT receive FDA 510(k) clearance?

FDP PLASMA TEST KIT received FDA 510(k) clearance on 1992-07-13, under 510(k) number K920943.

Who is the listed applicant for FDP PLASMA 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 FDP PLASMA TEST KIT?

The FDA product code for FDP PLASMA TEST KIT is DAP.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

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] KITK964728STA-LIATEST D-DI TEST KITK964718STA D-DI CALIBRATOR KITK962675STA - LIATEST VWF TEST 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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