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FDA 510(k)

TURBOX FIBRINOGEN

K-Number: K884179 · 1988-12-20

ApplicantUnipath , Ltd.
Decision Date1988-12-20
Product CodeKQJ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TURBOX FIBRINOGEN is the device name listed in this FDA 510(k) record. The listed applicant is Unipath , Ltd.. It received FDA 510(k) clearance on 1988-12-20 under 510(k) number K884179. 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 TURBOX FIBRINOGEN?

TURBOX FIBRINOGEN is a medical device that received FDA 510(k) clearance on 1988-12-20. The listed applicant is Unipath , Ltd.. The 510(k) number is K884179.

When did TURBOX FIBRINOGEN receive FDA 510(k) clearance?

TURBOX FIBRINOGEN received FDA 510(k) clearance on 1988-12-20, under 510(k) number K884179.

Who is the listed applicant for TURBOX FIBRINOGEN?

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

What is the FDA product code for TURBOX FIBRINOGEN?

The FDA product code for TURBOX FIBRINOGEN is KQJ.

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Other records listing Unipath , Ltd. 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.

K061769E.P.T. CERTAINTY 1-STEP PREGNANCY TESTK060128CLEARBLUE EASY DIGITAL PREGNANCY TESTK051638INVERNESS MEDICAL TESTPACK + PLUS STREP A WITH OBCK050930E.P.T. CERTAINTY PREGNANCY TESTK042280FACT PLUS ONE-STEP PREGNANCY TEST KITK041404CLEARBLUE EASY EASY READ PREGNANCY TEST

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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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