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FDA 510(k)

HEPARIN ADSORBENT

K-Number: K912061 · 1991-07-24

ApplicantSigma Diagnostics, Inc.
Decision Date1991-07-24
Product CodeJPA
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

HEPARIN ADSORBENT 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 1991-07-24 under 510(k) number K912061. 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 HEPARIN ADSORBENT?

HEPARIN ADSORBENT is a medical device that received FDA 510(k) clearance on 1991-07-24. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K912061.

When did HEPARIN ADSORBENT receive FDA 510(k) clearance?

HEPARIN ADSORBENT received FDA 510(k) clearance on 1991-07-24, under 510(k) number K912061.

Who is the listed applicant for HEPARIN ADSORBENT?

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 HEPARIN ADSORBENT?

The FDA product code for HEPARIN ADSORBENT is JPA.

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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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Related Devices (Code: 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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