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FDA 510(k)

CBC-5D HEMATOLOGY CONTROL

K-Number: K983032 · 1999-02-17

ApplicantR&D Systems, Inc.
Decision Date1999-02-17
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CBC-5D HEMATOLOGY CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is R&D Systems, Inc.. It received FDA 510(k) clearance on 1999-02-17 under 510(k) number K983032. 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 CBC-5D HEMATOLOGY CONTROL?

CBC-5D HEMATOLOGY CONTROL is a medical device that received FDA 510(k) clearance on 1999-02-17. The listed applicant is R&D Systems, Inc.. The 510(k) number is K983032.

When did CBC-5D HEMATOLOGY CONTROL receive FDA 510(k) clearance?

CBC-5D HEMATOLOGY CONTROL received FDA 510(k) clearance on 1999-02-17, under 510(k) number K983032.

Who is the listed applicant for CBC-5D HEMATOLOGY CONTROL?

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

What is the FDA product code for CBC-5D HEMATOLOGY CONTROL?

The FDA product code for CBC-5D HEMATOLOGY CONTROL is JPK.

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Other records listing R&D Systems, 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.

K160606BC-5D Hematology ControlK130962R&D 5D RETIC HEMATOLOGY CONTROLK101578R&D SYSTEMS BODY FLUID-I HEMATOLOGY CONTROLK100050R & D SYSTEMS XERET HEMATOLOGY CONTROLK091433R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROLK073178HCT EXTENDED HEMATOLOGY CONTROL, MODEL HCT004

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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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