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FDA 510(k)

ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY

K-Number: K843978 · 1984-12-18

ApplicantBehring Diagnostics, Inc.
Decision Date1984-12-18
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY is the device name listed in this FDA 510(k) record. The listed applicant is Behring Diagnostics, Inc.. It received FDA 510(k) clearance on 1984-12-18 under 510(k) number K843978. 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 ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY?

ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY is a medical device that received FDA 510(k) clearance on 1984-12-18. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K843978.

When did ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY receive FDA 510(k) clearance?

ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY received FDA 510(k) clearance on 1984-12-18, under 510(k) number K843978.

Who is the listed applicant for ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY?

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

What is the FDA product code for ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY?

The FDA product code for ENAII TEST KIT(SS-A(RO) & SS-B(LA) AUTOANTIBODY is LLL.

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Other records listing Behring Diagnostics, Inc. as applicant

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Related Devices (Code: 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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