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FDA 510(k)

FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3

K-Number: K946265 · 1995-08-24

ApplicantClinical Controls, Inc.
Decision Date1995-08-24
Product CodeGIL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 is the device name listed in this FDA 510(k) record. The listed applicant is Clinical Controls, Inc.. It received FDA 510(k) clearance on 1995-08-24 under 510(k) number K946265. The device is classified under product code GIL. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3?

FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 is a medical device that received FDA 510(k) clearance on 1995-08-24. The listed applicant is Clinical Controls, Inc.. The 510(k) number is K946265.

When did FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 receive FDA 510(k) clearance?

FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 received FDA 510(k) clearance on 1995-08-24, under 510(k) number K946265.

Who is the listed applicant for FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3?

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

What is the FDA product code for FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3?

The FDA product code for FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3 is GIL.

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Other records listing Clinical Controls, 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.

K964278WHOLE BLOOD GLUCOSE CONTROL LEVEL 1,2,AND 3/WHOLE BLOOD GLUCOSE LINEARITY CONTROL-LEVEL1,2,3,4,5,AND 6K962432LIQUISPEX URINE (MICRO)ALBUMIN CONTROLK955690AQUEOUS ETHANOL/AMMONIA CONTROL LEVEL 1, 2, & 3K955691SERUM VOLATILES CONTROL LEVEL 1 & 2K935598PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2K946048LIQUISPEX(TM) LIQUID B2M CONTROL LEVEL 1 AND 2

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Related Devices (Code: GIL)

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.

K962407N/T PROTEIN CONTROL PYBehring Diagnostics, Inc.K946193FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3More DiagnosticsK935598PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2Clinical Controls, Inc.K951012N/T PROTEIN CONTROL PYBehring Diagnostics, Inc.K934741LIQUID FIBRINOGEN FDP CONTROL LEVEL 1 & 2Clinical Controls, Inc.K915462FIBRINOGEN CONTROLSigma 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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