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FDA 510(k)

SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE

K-Number: K991876 · 1999-06-17

ApplicantR&D Systems, Inc.
Decision Date1999-06-17
Product CodeJPK
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE 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 1999-06-17 under 510(k) number K991876. 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 SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE?

SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE is a medical device that received FDA 510(k) clearance on 1999-06-17. The listed applicant is R&D Systems, Inc.. The 510(k) number is K991876.

When did SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE receive FDA 510(k) clearance?

SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE received FDA 510(k) clearance on 1999-06-17, under 510(k) number K991876.

Who is the listed applicant for SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE?

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 SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE?

The FDA product code for SEDRITE PLUS ERYTHROCYTE SEDIMENTATION RATE 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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