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FDA 510(k)

BONGROS HA

K-Number: K090793 · 2009-05-19

ApplicantBioalpha, Inc.
Decision Date2009-05-19
Product CodeLYC
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

BONGROS HA is the device name listed in this FDA 510(k) record. The listed applicant is Bioalpha, Inc.. It received FDA 510(k) clearance on 2009-05-19 under 510(k) number K090793. The device is classified under product code LYC. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BONGROS HA?

BONGROS HA is a medical device that received FDA 510(k) clearance on 2009-05-19. The listed applicant is Bioalpha, Inc.. The 510(k) number is K090793.

When did BONGROS HA receive FDA 510(k) clearance?

BONGROS HA received FDA 510(k) clearance on 2009-05-19, under 510(k) number K090793.

Who is the listed applicant for BONGROS HA?

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

What is the FDA product code for BONGROS HA?

The FDA product code for BONGROS HA is LYC.

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Related Devices (Code: LYC)

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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