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FDA 510(k)

GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL

K-Number: K833352 · 1983-11-03

ApplicantWarner-Lambert Co.
Decision Date1983-11-03
Product CodeGIL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Warner-Lambert Co.. It received FDA 510(k) clearance on 1983-11-03 under 510(k) number K833352. 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 GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL?

GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL is a medical device that received FDA 510(k) clearance on 1983-11-03. The listed applicant is Warner-Lambert Co.. The 510(k) number is K833352.

When did GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL receive FDA 510(k) clearance?

GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL received FDA 510(k) clearance on 1983-11-03, under 510(k) number K833352.

Who is the listed applicant for GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL?

The FDA 510(k) record lists Warner-Lambert Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL?

The FDA product code for GEN. DIAGNOSTICS LOW FIBRINOGEN CONTROL is GIL.

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Other records listing Warner-Lambert Co. 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.

K024160NEOSPORIN SCAR SOLUTIONK893452EXTRA STRENGTH EFFERGRIP DENTURE ADHESIVE CREAMK870584O.P.T.(TM) OVULATION PREDICTION TESTK861510MULTILUMEN VIAPIC CENTRAL LINE CATHETERK852967GENERAL DIAGNOSTICS' CEFTRIAXONE 30MCG SUSDEP DISKK852689GENERAL DIAGNOSTICS CEFTAZIDIME 30 MCG SUSC DISK

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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.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.

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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