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FDA 510(k)

FLOSTAT VASCULAR LAB

K-Number: K973644 · 1997-12-23

ApplicantBiomedix, Inc.
Decision Date1997-12-23
Product CodeJAF
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

FLOSTAT VASCULAR LAB is the device name listed in this FDA 510(k) record. The listed applicant is Biomedix, Inc.. It received FDA 510(k) clearance on 1997-12-23 under 510(k) number K973644. The device is classified under product code JAF. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FLOSTAT VASCULAR LAB?

FLOSTAT VASCULAR LAB is a medical device that received FDA 510(k) clearance on 1997-12-23. The listed applicant is Biomedix, Inc.. The 510(k) number is K973644.

When did FLOSTAT VASCULAR LAB receive FDA 510(k) clearance?

FLOSTAT VASCULAR LAB received FDA 510(k) clearance on 1997-12-23, under 510(k) number K973644.

Who is the listed applicant for FLOSTAT VASCULAR LAB?

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

What is the FDA product code for FLOSTAT VASCULAR LAB?

The FDA product code for FLOSTAT VASCULAR LAB is JAF.

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Other records listing Biomedix, 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.

K122281PADNET 2.0K073146PADNET+K050182Q.STEPS BIOMETER G/C DUAL MONITORING SYSTEMK042616BIOMEDIX PADNET LABK033627Q.STEPS BIOMETER G BLOOD GLUCOSE MONITORING SYSTEMK973857FLOSTAT VASCULAR REPORT GENERATOR (VRG)

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Related Devices (Code: JAF)

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.

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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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