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FDA 510(k)

DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET

K-Number: K872360 · 1987-07-06

ApplicantAmerican Dade
Decision Date1987-07-06
Product CodeGHH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1987-07-06 under 510(k) number K872360. The device is classified under product code GHH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET?

DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET is a medical device that received FDA 510(k) clearance on 1987-07-06. The listed applicant is American Dade. The 510(k) number is K872360.

When did DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET receive FDA 510(k) clearance?

DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET received FDA 510(k) clearance on 1987-07-06, under 510(k) number K872360.

Who is the listed applicant for DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET?

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

What is the FDA product code for DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET?

The FDA product code for DATA-FI FIBRIN(OGEN) DEGRADATION PROD.(FDP)DET SET is GHH.

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Other records listing American Dade 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.

K873051STRATUS(R) HFSH FLUOROMETRIC ENZYME IMMUNOASSAYK873171STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAYK873052STRATUS(R) HLH FLUOROMETRIC ENZYME IMMUNOASSAYK872789PARAMAX URINE/CSF CALIBRATORK872195DATA-FI DIMERTEST LATEX ASSAYK872196AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III

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Related Devices (Code: GHH)

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.

K112120DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SETDiazyme LaboratoriesK072288PATHFAST D-DIMERMitsubishi Kagaku IatronK070453OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROLOlympus Life & Material Science Europa GmbH (IrishK062203TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.K042890TRIAGE D-DIMER TEST, MODEL 98100Biosite IncorporatedK030740MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEMRoche 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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