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FDA 510(k)

ANTI-DNASE B REAGENT SYSTEM

K-Number: K790997 · 1979-07-24

ApplicantCalbiochem-Behring Corp.
Decision Date1979-07-24
Product CodeGTR
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

ANTI-DNASE B REAGENT SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Calbiochem-Behring Corp.. It received FDA 510(k) clearance on 1979-07-24 under 510(k) number K790997. The device is classified under product code GTR. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANTI-DNASE B REAGENT SYSTEM?

ANTI-DNASE B REAGENT SYSTEM is a medical device that received FDA 510(k) clearance on 1979-07-24. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K790997.

When did ANTI-DNASE B REAGENT SYSTEM receive FDA 510(k) clearance?

ANTI-DNASE B REAGENT SYSTEM received FDA 510(k) clearance on 1979-07-24, under 510(k) number K790997.

Who is the listed applicant for ANTI-DNASE B REAGENT SYSTEM?

The FDA 510(k) record lists Calbiochem-Behring Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ANTI-DNASE B REAGENT SYSTEM?

The FDA product code for ANTI-DNASE B REAGENT SYSTEM is GTR.

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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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