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FDA 510(k)

MSI-HB HEMOGLOBIN CONTROL

K-Number: K853776 · 1985-09-19

ApplicantMedical Specialties, Inc.
Decision Date1985-09-19
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

MSI-HB HEMOGLOBIN CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Medical Specialties, Inc.. It received FDA 510(k) clearance on 1985-09-19 under 510(k) number K853776. 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 MSI-HB HEMOGLOBIN CONTROL?

MSI-HB HEMOGLOBIN CONTROL is a medical device that received FDA 510(k) clearance on 1985-09-19. The listed applicant is Medical Specialties, Inc.. The 510(k) number is K853776.

When did MSI-HB HEMOGLOBIN CONTROL receive FDA 510(k) clearance?

MSI-HB HEMOGLOBIN CONTROL received FDA 510(k) clearance on 1985-09-19, under 510(k) number K853776.

Who is the listed applicant for MSI-HB HEMOGLOBIN CONTROL?

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

What is the FDA product code for MSI-HB HEMOGLOBIN CONTROL?

The FDA product code for MSI-HB HEMOGLOBIN CONTROL is JPK.

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Other records listing Medical Specialties, 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.

K946201STAND, INFUSIONK931947CHECKPOINTK926095REFRACTROL-SPK924926MSI-HCTK896566MODIFIED FOX EXTRA GRAM NEGATIVE AND POSITIVEK883851MSI-CAL 8

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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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