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FDA 510(k)

HBF-QUIPLATE METHODOLOGY

K-Number: K780807 · 1978-06-02

ApplicantHelena Laboratories
Decision Date1978-06-02
Product CodeJBD
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HBF-QUIPLATE METHODOLOGY is the device name listed in this FDA 510(k) record. The listed applicant is Helena Laboratories. It received FDA 510(k) clearance on 1978-06-02 under 510(k) number K780807. The device is classified under product code JBD. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HBF-QUIPLATE METHODOLOGY?

HBF-QUIPLATE METHODOLOGY is a medical device that received FDA 510(k) clearance on 1978-06-02. The listed applicant is Helena Laboratories. The 510(k) number is K780807.

When did HBF-QUIPLATE METHODOLOGY receive FDA 510(k) clearance?

HBF-QUIPLATE METHODOLOGY received FDA 510(k) clearance on 1978-06-02, under 510(k) number K780807.

Who is the listed applicant for HBF-QUIPLATE METHODOLOGY?

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 HBF-QUIPLATE METHODOLOGY?

The FDA product code for HBF-QUIPLATE METHODOLOGY is JBD.

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Related Devices (Code: JBD)

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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