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FDA 510(k)

FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3

K-Number: K946193 · 1995-08-24

ApplicantMore Diagnostics
Decision Date1995-08-24
Product CodeGIL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 is the device name listed in this FDA 510(k) record. The listed applicant is More Diagnostics. It received FDA 510(k) clearance on 1995-08-24 under 510(k) number K946193. 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 CONTROL (HUMAN) LEVEL 1, 2, 3?

FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 is a medical device that received FDA 510(k) clearance on 1995-08-24. The listed applicant is More Diagnostics. The 510(k) number is K946193.

When did FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 receive FDA 510(k) clearance?

FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 received FDA 510(k) clearance on 1995-08-24, under 510(k) number K946193.

Who is the listed applicant for FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3?

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

What is the FDA product code for FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3?

The FDA product code for FIBRINOGEN CONTROL (HUMAN) LEVEL 1, 2, 3 is GIL.

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Other records listing More Diagnostics 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.

K072257MYCOPHENOLIC ACID CONTROL, LEVEL 1, 2, 3, 4, 4-LEVELK050125RAP/TAC/CSA CONTROL - LEVEL 1,2,3,4K982845CARDIAC MARKERS CONTROL (SINGLE USE)-LEVELS, 1,2,3, MODELS NUMBER 175-1, 175-2, 175-3K980331IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\SK972976CARDIAC MARKERS CONTROL - LEVEL 1, LEVEL 2, LEVEL 3, TRI-LEVELK970778LEAD CONTROL (WHOLE BLOOD) LEVELS 1,2,3,4

View all 16 devices →

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.K946265FIBRINOGEN HIGH ABNORMAL CONTROL - LEVEL 3Clinical Controls, Inc.K935598PLASMA 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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