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FDA 510(k)

PR 3 ANTIBODY KIT

K-Number: K973823 · 1997-11-13

ApplicantHemagen Diagnostics, Inc.
Decision Date1997-11-13
Product CodeMOB
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

PR 3 ANTIBODY KIT is the device name listed in this FDA 510(k) record. The listed applicant is Hemagen Diagnostics, Inc.. It received FDA 510(k) clearance on 1997-11-13 under 510(k) number K973823. The device is classified under product code MOB. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PR 3 ANTIBODY KIT?

PR 3 ANTIBODY KIT is a medical device that received FDA 510(k) clearance on 1997-11-13. The listed applicant is Hemagen Diagnostics, Inc.. The 510(k) number is K973823.

When did PR 3 ANTIBODY KIT receive FDA 510(k) clearance?

PR 3 ANTIBODY KIT received FDA 510(k) clearance on 1997-11-13, under 510(k) number K973823.

Who is the listed applicant for PR 3 ANTIBODY KIT?

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

What is the FDA product code for PR 3 ANTIBODY KIT?

The FDA product code for PR 3 ANTIBODY KIT is MOB.

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Related Devices (Code: MOB)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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