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FDA 510(k)

OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376

K-Number: K926222 · 1993-02-12

ApplicantHelena Laboratories
Decision Date1993-02-12
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376 is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1993-02-12 under 510(k) number K926222. The device is classified under product code JPA. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376?

OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376 is a medical device that received FDA 510(k) clearance on 1993-02-12. The listed applicant is Helena Laboratories. The 510(k) number is K926222.

When did OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376 receive FDA 510(k) clearance?

OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376 received FDA 510(k) clearance on 1993-02-12, under 510(k) number K926222.

Who is the listed applicant for OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376?

The FDA 510(k) record lists Helena Laboratories as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376?

The FDA product code for OWREN'S VERONAL BUFFER #5375 & FIBRONOGEN KIT#5376 is JPA.

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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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