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FDA 510(k)

SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS

K-Number: K800780 · 1980-04-24

ApplicantSandare Chemical Co., Inc.
Decision Date1980-04-24
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Sandare Chemical Co., Inc.. It received FDA 510(k) clearance on 1980-04-24 under 510(k) number K800780. The device is classified under product code JPK. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS?

SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS is a medical device that received FDA 510(k) clearance on 1980-04-24. The listed applicant is Sandare Chemical Co., Inc.. The 510(k) number is K800780.

When did SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS receive FDA 510(k) clearance?

SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS received FDA 510(k) clearance on 1980-04-24, under 510(k) number K800780.

Who is the listed applicant for SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS?

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

What is the FDA product code for SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS?

The FDA product code for SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS is JPK.

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Other records listing Sandare Chemical Co., 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.

K872852EAGLE DIAGNOSTICS GLYCOHEMOGLOBIN UNITIZED TESTK862556SANDARE GLYCOHEMOGLOBIN PROCEDUREK860684SANDARE BCG ALBUMIN PROCEDUREK851395SANDARE IRON-BINDING CAPACITY PROCEDUREK851394SANDARE IRON PROCEDUREK844498SANDARE ALKALINE PHOSPHATASE PROCEDURE

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Related Devices (Code: JPK)

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.

K160586XN-L CHECKStreckK160590XN CHECKStreckK160588XN CHECK BFStreckK160606BC-5D Hematology ControlR&D Systems, Inc.K130962R&D 5D RETIC HEMATOLOGY CONTROLR&D Systems, Inc.K120744XN CHECK BFStreck

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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