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FDA 510(k)

ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW

K-Number: K820401 · 1982-03-15

ApplicantOrhto Diagnostic Systems, Inc.
Decision Date1982-03-15
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW is the device name listed in this FDA 510(k) record. The listed applicant is Orhto Diagnostic Systems, Inc.. It received FDA 510(k) clearance on 1982-03-15 under 510(k) number K820401. 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 ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW?

ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW is a medical device that received FDA 510(k) clearance on 1982-03-15. The listed applicant is Orhto Diagnostic Systems, Inc.. The 510(k) number is K820401.

When did ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW receive FDA 510(k) clearance?

ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW received FDA 510(k) clearance on 1982-03-15, under 510(k) number K820401.

Who is the listed applicant for ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW?

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

What is the FDA product code for ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW?

The FDA product code for ORTHO* HEMATOLOGY CONTR. 8 ABN. HI/LOW is JPK.

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Related Devices (Code: JPK)

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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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