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FDA 510(k)

ANA SENSITIVITY/SPECIFICITY CONTROL

K-Number: K841776 · 1984-06-22

ApplicantBehring Diagnostics, Inc.
Decision Date1984-06-22
Product CodeDHN
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

ANA SENSITIVITY/SPECIFICITY CONTROL 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 1984-06-22 under 510(k) number K841776. The device is classified under product code DHN. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ANA SENSITIVITY/SPECIFICITY CONTROL?

ANA SENSITIVITY/SPECIFICITY CONTROL is a medical device that received FDA 510(k) clearance on 1984-06-22. The listed applicant is Behring Diagnostics, Inc.. The 510(k) number is K841776.

When did ANA SENSITIVITY/SPECIFICITY CONTROL receive FDA 510(k) clearance?

ANA SENSITIVITY/SPECIFICITY CONTROL received FDA 510(k) clearance on 1984-06-22, under 510(k) number K841776.

Who is the listed applicant for ANA SENSITIVITY/SPECIFICITY CONTROL?

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 ANA SENSITIVITY/SPECIFICITY CONTROL?

The FDA product code for ANA SENSITIVITY/SPECIFICITY CONTROL is DHN.

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Other records listing Behring Diagnostics, Inc. as applicant

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Related Devices (Code: DHN)

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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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