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FDA 510(k)

CEPHALINEX ACTIVATED PTT REAGENT

K-Number: K852195 · 1985-08-12

ApplicantBio/Data Corp.
Decision Date1985-08-12
Product CodeGGW
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CEPHALINEX ACTIVATED PTT REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Bio/Data Corp.. It received FDA 510(k) clearance on 1985-08-12 under 510(k) number K852195. The device is classified under product code GGW. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CEPHALINEX ACTIVATED PTT REAGENT?

CEPHALINEX ACTIVATED PTT REAGENT is a medical device that received FDA 510(k) clearance on 1985-08-12. The listed applicant is Bio/Data Corp.. The 510(k) number is K852195.

When did CEPHALINEX ACTIVATED PTT REAGENT receive FDA 510(k) clearance?

CEPHALINEX ACTIVATED PTT REAGENT received FDA 510(k) clearance on 1985-08-12, under 510(k) number K852195.

Who is the listed applicant for CEPHALINEX ACTIVATED PTT REAGENT?

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

What is the FDA product code for CEPHALINEX ACTIVATED PTT REAGENT?

The FDA product code for CEPHALINEX ACTIVATED PTT REAGENT is GGW.

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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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