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FDA 510(k)

ENA TEST KIT SM & RNP AUTO ANTIBODY

K-Number: K831036 · 1983-04-27

ApplicantCalbiochem-Behring Corp.
Decision Date1983-04-27
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENA TEST KIT SM & RNP AUTO ANTIBODY 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 1983-04-27 under 510(k) number K831036. The device is classified under product code LLL. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ENA TEST KIT SM & RNP AUTO ANTIBODY?

ENA TEST KIT SM & RNP AUTO ANTIBODY is a medical device that received FDA 510(k) clearance on 1983-04-27. The listed applicant is Calbiochem-Behring Corp.. The 510(k) number is K831036.

When did ENA TEST KIT SM & RNP AUTO ANTIBODY receive FDA 510(k) clearance?

ENA TEST KIT SM & RNP AUTO ANTIBODY received FDA 510(k) clearance on 1983-04-27, under 510(k) number K831036.

Who is the listed applicant for ENA TEST KIT SM & RNP AUTO ANTIBODY?

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 ENA TEST KIT SM & RNP AUTO ANTIBODY?

The FDA product code for ENA TEST KIT SM & RNP AUTO ANTIBODY is LLL.

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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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