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FDA 510(k)

PLATELET CONTROLS NORMAL & ABNORMAL

K-Number: K771588 · 1977-08-25

ApplicantDade, Baxter Travenol Diagnostics, Inc.
Decision Date1977-08-25
Product CodeGJP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELET CONTROLS NORMAL & ABNORMAL is the device name listed in this FDA 510(k) record. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. It received FDA 510(k) clearance on 1977-08-25 under 510(k) number K771588. The device is classified under product code GJP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATELET CONTROLS NORMAL & ABNORMAL?

PLATELET CONTROLS NORMAL & ABNORMAL is a medical device that received FDA 510(k) clearance on 1977-08-25. The listed applicant is Dade, Baxter Travenol Diagnostics, Inc.. The 510(k) number is K771588.

When did PLATELET CONTROLS NORMAL & ABNORMAL receive FDA 510(k) clearance?

PLATELET CONTROLS NORMAL & ABNORMAL received FDA 510(k) clearance on 1977-08-25, under 510(k) number K771588.

Who is the listed applicant for PLATELET CONTROLS NORMAL & ABNORMAL?

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

What is the FDA product code for PLATELET CONTROLS NORMAL & ABNORMAL?

The FDA product code for PLATELET CONTROLS NORMAL & ABNORMAL is GJP.

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Other records listing Dade, Baxter Travenol Diagnostics, Inc. as applicant

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K800296WHOLE BLOOD GAS CONTROL, LEVELS 1,2,&3K792606WHOLE BLOOD PLATELET CONTROL NORMAL,K792723BLOOD FLUID FILTERSK792607T3 UPTAKE (T3U) REAGENTSK792443TSH RADIOIMMUNOASSAYK792442FERRITIN RADIOIMMUNOASSAY

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Related Devices (Code: GJP)

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.

K880608MSI-PCMedical Specialties, Inc.K823930HEMATOLOGY QUALITY CONTROL MIXTUREFisher Scientific Co., LLCK770655LATELET DETERMIBATION KIT, UL 800Bd Becton Dickinson Vacutainer Systems Preanalytic

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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