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FDA 510(k)

INFINITY HBA KIT, MODELS 537-A, 537-B

K-Number: K012410 · 2001-10-26

ApplicantSigma Diagnostics, Inc.
Decision Date2001-10-26
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

INFINITY HBA KIT, MODELS 537-A, 537-B is the device name listed in this FDA 510(k) record. The listed applicant is Sigma Diagnostics, Inc.. It received FDA 510(k) clearance on 2001-10-26 under 510(k) number K012410. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INFINITY HBA KIT, MODELS 537-A, 537-B?

INFINITY HBA KIT, MODELS 537-A, 537-B is a medical device that received FDA 510(k) clearance on 2001-10-26. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K012410.

When did INFINITY HBA KIT, MODELS 537-A, 537-B receive FDA 510(k) clearance?

INFINITY HBA KIT, MODELS 537-A, 537-B received FDA 510(k) clearance on 2001-10-26, under 510(k) number K012410.

Who is the listed applicant for INFINITY HBA KIT, MODELS 537-A, 537-B?

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

What is the FDA product code for INFINITY HBA KIT, MODELS 537-A, 537-B?

The FDA product code for INFINITY HBA KIT, MODELS 537-A, 537-B is LCP.

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Related Devices (Code: LCP)

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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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