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FDA 510(k)

FIBRINOGEN CONTROL PLASMA

K-Number: K811069 · 1981-07-10

ApplicantAmerican Dade
Decision Date1981-07-10
Product CodeKQJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FIBRINOGEN CONTROL PLASMA is the device name listed in this FDA 510(k) record. The listed applicant is American Dade. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811069. The device is classified under product code KQJ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRINOGEN CONTROL PLASMA?

FIBRINOGEN CONTROL PLASMA is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is American Dade. The 510(k) number is K811069.

When did FIBRINOGEN CONTROL PLASMA receive FDA 510(k) clearance?

FIBRINOGEN CONTROL PLASMA received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811069.

Who is the listed applicant for FIBRINOGEN CONTROL PLASMA?

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 FIBRINOGEN CONTROL PLASMA?

The FDA product code for FIBRINOGEN CONTROL PLASMA is KQJ.

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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

View all 149 devices →

Related Devices (Code: KQJ)

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.

K251968HemosIL Fibrinogen-C; HemosIL Fibrinogen-C XLInstrumentation Laboratory (IL) Co.K073367HEMOSIL FIBRINOGEN-CInstrumentation Laboratory COK050928DADE THROMBIN REAGENTDade Behring, Inc.K971858SIGMA DIAGNOSTICS FIBRINOGEN KIT (886A/887A)Sigma Diagnostics, Inc.K970189FIF TMPanbio, Inc.K965113N-ASSAY TIA FIBRINOGEN TEST KITCrestat Diagnostics, Inc.

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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