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FDA 510(k)

SPECTROLYSE FACTOR VII:C

K-Number: K934584 · 1993-12-06

ApplicantMeditech, Inc.
Decision Date1993-12-06
Product CodeGGP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SPECTROLYSE FACTOR VII:C is the device name listed in this FDA 510(k) record. The listed applicant is Meditech, Inc.. It received FDA 510(k) clearance on 1993-12-06 under 510(k) number K934584. 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 SPECTROLYSE FACTOR VII:C?

SPECTROLYSE FACTOR VII:C is a medical device that received FDA 510(k) clearance on 1993-12-06. The listed applicant is Meditech, Inc.. The 510(k) number is K934584.

When did SPECTROLYSE FACTOR VII:C receive FDA 510(k) clearance?

SPECTROLYSE FACTOR VII:C received FDA 510(k) clearance on 1993-12-06, under 510(k) number K934584.

Who is the listed applicant for SPECTROLYSE FACTOR VII:C?

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

What is the FDA product code for SPECTROLYSE FACTOR VII:C?

The FDA product code for SPECTROLYSE FACTOR VII:C is GGP.

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Related Devices (Code: GGP)

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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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