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FDA 510(k)

DADE(R) PROTEIN C ABNORMAL CONTRAL

K-Number: K911885 · 1991-06-11

ApplicantBaxter Healthcare Corp
Decision Date1991-06-11
Product CodeGGC
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

DADE(R) PROTEIN C ABNORMAL CONTRAL is the device name listed in this FDA 510(k) record. The listed applicant is Baxter Healthcare Corp. It received FDA 510(k) clearance on 1991-06-11 under 510(k) number K911885. The device is classified under product code GGC. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DADE(R) PROTEIN C ABNORMAL CONTRAL?

DADE(R) PROTEIN C ABNORMAL CONTRAL is a medical device that received FDA 510(k) clearance on 1991-06-11. The listed applicant is Baxter Healthcare Corp. The 510(k) number is K911885.

When did DADE(R) PROTEIN C ABNORMAL CONTRAL receive FDA 510(k) clearance?

DADE(R) PROTEIN C ABNORMAL CONTRAL received FDA 510(k) clearance on 1991-06-11, under 510(k) number K911885.

Who is the listed applicant for DADE(R) PROTEIN C ABNORMAL CONTRAL?

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

What is the FDA product code for DADE(R) PROTEIN C ABNORMAL CONTRAL?

The FDA product code for DADE(R) PROTEIN C ABNORMAL CONTRAL is GGC.

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Other records listing Baxter Healthcare Corp as applicant

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Related Devices (Code: GGC)

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.

K102552HEMOSIL LA POSITIVE CONTROLInstrumentation Laboratory COK100103SPECIALTY ASSAYED CONTROL-2Helena LaboratoriesK062306PLASMACON N, PLASMACON L-1, PLASMACON L-2R2 Diagnostics, Inc.K061803STA - CONTROL LA 1+2Diagnostica Stago, Inc.K032804CRYOCHECK WEAK LUPUS POSITIVE CONTROLPrecision BiologicK023312CONTROL PLASMA PDade Behring, 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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