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FDA 510(k)

FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527

K-Number: K880038 · 1988-04-21

ApplicantSigma Diagnostics, Inc.
Decision Date1988-04-21
Product CodeKHG
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 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 1988-04-21 under 510(k) number K880038. The device is classified under product code KHG. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527?

FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 is a medical device that received FDA 510(k) clearance on 1988-04-21. The listed applicant is Sigma Diagnostics, Inc.. The 510(k) number is K880038.

When did FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 receive FDA 510(k) clearance?

FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 received FDA 510(k) clearance on 1988-04-21, under 510(k) number K880038.

Who is the listed applicant for FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527?

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 FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527?

The FDA product code for FOR THE DETER. OF HEMOGLOBIN IN PLASMA #527 is KHG.

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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.

K021162AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHEDK020109SIGMA DIAGNOSTICS ACCUCLOT LA CONTROLK013549SIGMA DIAGNOSTICS AUTO D-DIMER CALIBRATOR, MODEL A7971K013544SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 2, MODEL A8096K013545SIGMA DIAGNOSTICS AUTO D-DIMER CONTROL, LEVEL 3, MODEL A8221K012410INFINITY HBA KIT, MODELS 537-A, 537-B

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Related Devices (Code: KHG)

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.

K221508AnemoCheck HomeSanguina, Inc.K163215AnemoCheckSanguina, LLCK042379ANEMIAPRO SELF-SCREENERBiosafe Laboratories, Inc.K020138STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090Gds TechnologyK001462CARESIDE HEMOGLOBINCareside, Inc.K994073HEMOSITE TEST SYSTEMGds Technology, LLC

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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