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FDA 510(k)

N/T PROTEIN CONTROL PY

K-Number: K951012 · 1995-04-17

ApplicantBehring Diagnostics, Inc.
Decision Date1995-04-17
Product CodeGIL
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

N/T PROTEIN CONTROL PY is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1995-04-17 under 510(k) number K951012. 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 N/T PROTEIN CONTROL PY?

N/T PROTEIN CONTROL PY is a medical device that received FDA 510(k) clearance on 1995-04-17. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K951012.

When did N/T PROTEIN CONTROL PY receive FDA 510(k) clearance?

N/T PROTEIN CONTROL PY received FDA 510(k) clearance on 1995-04-17, under 510(k) number K951012.

Who is the listed applicant for N/T PROTEIN CONTROL PY?

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

What is the FDA product code for N/T PROTEIN CONTROL PY?

The FDA product code for N/T PROTEIN CONTROL PY is GIL.

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Other records listing Behring Diagnostics, 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.

K973832OPUS HLH CONTROLSK972929N ANTISERUM TO HUMAN ALBUMINK972840N ANTISERUM TO HUMAN TRANSFERRINK973202MODIFICATION OF OPUS FERRITIN TEST SYSTEMK972316OPUS D-DIMERK972116VON WILLEBRAND REAGENT

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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.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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