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FDA 510(k)

AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER

K-Number: K964406 · 1997-09-25

ApplicantDaxor Corporation
Decision Date1997-09-25
Product CodeJWO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Daxor Corporation. It received FDA 510(k) clearance on 1997-09-25 under 510(k) number K964406. The device is classified under product code JWO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER?

AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER is a medical device that received FDA 510(k) clearance on 1997-09-25. The listed applicant is Daxor Corporation. The 510(k) number is K964406.

When did AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER receive FDA 510(k) clearance?

AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER received FDA 510(k) clearance on 1997-09-25, under 510(k) number K964406.

Who is the listed applicant for AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER?

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

What is the FDA product code for AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER?

The FDA product code for AUTOMATED MULTI-POINT BLOOD VOLUME ANALYZER is JWO.

Related Clinical Trials

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Other records listing Daxor Corporation 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.

K261099Blood Volume Analyzer (200)K251087Blood Volume Analyzer (200)K970419DAXOR MAX100 SYRINGE (MAX100)

Related Devices (Code: JWO)

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.

K261099Blood Volume Analyzer (200)Daxor CorporationK251087Blood Volume Analyzer (200)Daxor Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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