Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK

K-Number: K063356 · 2007-03-23

ApplicantDade Behring, Inc.
Decision Date2007-03-23
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2007-03-23 under 510(k) number K063356. 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 STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK?

STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK is a medical device that received FDA 510(k) clearance on 2007-03-23. The listed applicant is Dade Behring, Inc.. The 510(k) number is K063356.

When did STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK receive FDA 510(k) clearance?

STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK received FDA 510(k) clearance on 2007-03-23, under 510(k) number K063356.

Who is the listed applicant for STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK?

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

What is the FDA product code for STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK?

The FDA product code for STRATUS CS ACUTE CARE D-DIMER TESTPAK, DILPAK, CALPAK 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 Dade Behring, 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.

K093848PT-MULTI-CALIBRATOR, MODEL OPAT07K081161DIMENSION VISTA SYSTEM IGG FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, AND DIMENSION VISTA SYSTK081249DIMENSION VISTA SYSTEM A2MAC FLEX REAGENT CARTRIDGE, DIMENSION VISTA SYSTEM PROTEIN 1 CALIBRATOR, DIMENSION VISTA SYSYEMK071603DIMENSION VISTA CARCINOEMBRYONIC ANTIGEN FLEX REAGENT CARTRIDGE (CEA)K071597DIMENSION VISTA (R) AFP FLEX(R) REAGENT CARTRIDGE, MODEL K6454, DIMENSION VISTA (R) LOCI 5 CALIBRATOR, MODEL KC600K073604DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD

View all 343 devices →

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.

↑