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FDA 510(k)

BIOCLOT PROTEIN S

K-Number: K955738 · 1996-02-29

ApplicantMedical Diagnostic Technologies, Inc.
Decision Date1996-02-29
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

BIOCLOT PROTEIN S is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Technologies, Inc.. It received FDA 510(k) clearance on 1996-02-29 under 510(k) number K955738. The device is classified under product code GGP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIOCLOT PROTEIN S?

BIOCLOT PROTEIN S is a medical device that received FDA 510(k) clearance on 1996-02-29. The listed applicant is Medical Diagnostic Technologies, Inc.. The 510(k) number is K955738.

When did BIOCLOT PROTEIN S receive FDA 510(k) clearance?

BIOCLOT PROTEIN S received FDA 510(k) clearance on 1996-02-29, under 510(k) number K955738.

Who is the listed applicant for BIOCLOT PROTEIN S?

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

What is the FDA product code for BIOCLOT PROTEIN S?

The FDA product code for BIOCLOT PROTEIN S is GGP.

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Official Source

View on FDA Database →

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