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FDA 510(k)

HEMAVIEW DARKFIELD MICROSCOPE SYSTEM

K-Number: K885091 · 1989-06-13

ApplicantTechnalysis, Inc.
Decision Date1989-06-13
Product CodeIBM
Advisory CommitteePA
DecisionSubstantially Equivalent

Device Summary

HEMAVIEW DARKFIELD MICROSCOPE SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Technalysis, Inc.. It received FDA 510(k) clearance on 1989-06-13 under 510(k) number K885091. The device is classified under product code IBM. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HEMAVIEW DARKFIELD MICROSCOPE SYSTEM?

HEMAVIEW DARKFIELD MICROSCOPE SYSTEM is a medical device that received FDA 510(k) clearance on 1989-06-13. The listed applicant is Technalysis, Inc.. The 510(k) number is K885091.

When did HEMAVIEW DARKFIELD MICROSCOPE SYSTEM receive FDA 510(k) clearance?

HEMAVIEW DARKFIELD MICROSCOPE SYSTEM received FDA 510(k) clearance on 1989-06-13, under 510(k) number K885091.

Who is the listed applicant for HEMAVIEW DARKFIELD MICROSCOPE SYSTEM?

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

What is the FDA product code for HEMAVIEW DARKFIELD MICROSCOPE SYSTEM?

The FDA product code for HEMAVIEW DARKFIELD MICROSCOPE SYSTEM is IBM.

Related Clinical Trials

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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Other records listing Technalysis, 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.

K923773CELLEXIS HEMATOLOGY ANALYZERK905600TECHLYTE ELECTROLYTE ANALYZER

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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