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FDA 510(k)

PLATELET RETENTION (ADHESION) COLUMNS

K-Number: K800037 · 1980-02-05

ApplicantHemometrix
Decision Date1980-02-05
Product CodeJBZ
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

PLATELET RETENTION (ADHESION) COLUMNS is the device name listed in this FDA 510(k) record. The listed applicant is Hemometrix. It received FDA 510(k) clearance on 1980-02-05 under 510(k) number K800037. The device is classified under product code JBZ. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PLATELET RETENTION (ADHESION) COLUMNS?

PLATELET RETENTION (ADHESION) COLUMNS is a medical device that received FDA 510(k) clearance on 1980-02-05. The listed applicant is Hemometrix. The 510(k) number is K800037.

When did PLATELET RETENTION (ADHESION) COLUMNS receive FDA 510(k) clearance?

PLATELET RETENTION (ADHESION) COLUMNS received FDA 510(k) clearance on 1980-02-05, under 510(k) number K800037.

Who is the listed applicant for PLATELET RETENTION (ADHESION) COLUMNS?

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

What is the FDA product code for PLATELET RETENTION (ADHESION) COLUMNS?

The FDA product code for PLATELET RETENTION (ADHESION) COLUMNS is JBZ.

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Other records listing Hemometrix 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.

K792261GENTAMICIN CONTROL SERUMK792263TOBRAMYCIN CONTROL SERUMK792260AMIKACIN LIQUID CONTROL SERUMK792264TOBRAMYCIN LIQUID CONTROL SERUMK792262GENTAMICIN LIQUID CONTROL SERUMK792259AMIKACIN CONTROL SERUM

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Related Devices (Code: JBZ)

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.

K771523LATELET RETENTION COLUMNBd Becton Dickinson Vacutainer Systems PreanalyticK771678THROMBO-SCREEN PLATELET ADHESIONBay Area Hema. Onco. Clinic. & Res. L

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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