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FDA 510(k)

FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN

K-Number: K812298 · 1981-12-17

ApplicantSyn-Kit, Inc.
Decision Date1981-12-17
Product CodeGHH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN is the device name listed in this FDA 510(k) record. The listed applicant is Syn-Kit, Inc.. It received FDA 510(k) clearance on 1981-12-17 under 510(k) number K812298. 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 FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN?

FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN is a medical device that received FDA 510(k) clearance on 1981-12-17. The listed applicant is Syn-Kit, Inc.. The 510(k) number is K812298.

When did FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN receive FDA 510(k) clearance?

FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN received FDA 510(k) clearance on 1981-12-17, under 510(k) number K812298.

Who is the listed applicant for FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN?

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

What is the FDA product code for FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN?

The FDA product code for FIBROGEN(FIBRIN SPLIT PRODUCT) ANTIGEN is GHH.

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Other records listing Syn-Kit, 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.

K861098SEROIDEN STREPTO KIT 'EIKEN'K861631SLIDE CULTURE U 'EIKEN'K854819CPR SLIDE EIKENK854820RA 80 EIKENK853276ASO SLIDE EIKENK843758UROPAPER EIKEN GK

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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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