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)

FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2

K-Number: K932657 · 1993-11-02

ApplicantMore Diagnostics
Decision Date1993-11-02
Product CodeDAP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 is the device name listed in this FDA 510(k) record. The listed applicant is More Diagnostics. It received FDA 510(k) clearance on 1993-11-02 under 510(k) number K932657. 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 FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2?

FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 is a medical device that received FDA 510(k) clearance on 1993-11-02. The listed applicant is More Diagnostics. The 510(k) number is K932657.

When did FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 receive FDA 510(k) clearance?

FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 received FDA 510(k) clearance on 1993-11-02, under 510(k) number K932657.

Who is the listed applicant for FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2?

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

What is the FDA product code for FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2?

The FDA product code for FIBRIN(OGEN) FDP CONTROL LEVEL 1 & LEVEL 2 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 More Diagnostics 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.

K072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELK050125RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4K982845CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3K980331IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\SK972976CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVELK970778LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4

View all 16 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.

↑