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FDA 510(k)

PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2

K-Number: K935598 · 1995-05-02

ApplicantClinical Controls, Inc.
Decision Date1995-05-02
Product CodeGIL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 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 1995-05-02 under 510(k) number K935598. 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 PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2?

PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 is a medical device that received FDA 510(k) clearance on 1995-05-02. The listed applicant is Clinical Controls, Inc.. The 510(k) number is K935598.

When did PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 receive FDA 510(k) clearance?

PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 received FDA 510(k) clearance on 1995-05-02, under 510(k) number K935598.

Who is the listed applicant for PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2?

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 PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2?

The FDA product code for PLASMA FIBRINOGEN CONTROL LEVEL 1/LEVEL 2 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 & 2K946265FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3K946048LIQUISPEX(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 DiagnosticsK946265FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3Clinical 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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