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FDA 510(k)

SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094

K-Number: K992711 · 1999-12-06

ApplicantSigma Diagnostics, Inc.
Decision Date1999-12-06
Product CodeGFO
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 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 1999-12-06 under 510(k) number K992711. The device is classified under product code GFO. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094?

SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 is a medical device that received FDA 510(k) clearance on 1999-12-06. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K992711.

When did SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 receive FDA 510(k) clearance?

SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 received FDA 510(k) clearance on 1999-12-06, under 510(k) number K992711.

Who is the listed applicant for SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094?

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 SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094?

The FDA product code for SIGMA DIAGNOSTICS ALEXIN HS, MODELS A0969, A1094 is GFO.

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Other records listing Sigma Diagnostics, Inc. as applicant

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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