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FDA 510(k)

ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS)

K-Number: K871994 · 1987-08-12

ApplicantBehring Diagnostics, Inc.
Decision Date1987-08-12
Product CodeLLL
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS) 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 1987-08-12 under 510(k) number K871994. 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 III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS)?

ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS) is a medical device that received FDA 510(k) clearance on 1987-08-12. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K871994.

When did ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS) receive FDA 510(k) clearance?

ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS) received FDA 510(k) clearance on 1987-08-12, under 510(k) number K871994.

Who is the listed applicant for ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS)?

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 ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS)?

The FDA product code for ENA III TEST KIT (SCL-70 AUTOANTIBODY REAGENTS) 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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