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FDA 510(k)

CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE

K-Number: K934497 · 1993-12-06

ApplicantR&D Systems, Inc.
Decision Date1993-12-06
Product CodeJCN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE 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 1993-12-06 under 510(k) number K934497. The device is classified under product code JCN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE?

CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE is a medical device that received FDA 510(k) clearance on 1993-12-06. The listed applicant is R&D Systems, Inc.. The 510(k) number is K934497.

When did CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE receive FDA 510(k) clearance?

CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE received FDA 510(k) clearance on 1993-12-06, under 510(k) number K934497.

Who is the listed applicant for CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE?

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-STK(TM) HEMATOLOGY CONTROL/MULTIPLE?

The FDA product code for CBC-STK(TM) HEMATOLOGY CONTROL/MULTIPLE is JCN.

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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: JCN)

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.

K993825PARA TECH PLUS RETICSStreck Laboratories, Inc.K942209LIQUICHEK HEMATOLOGY-16 CONTROL, LOW, NORMAL AND HIGHBio-RadK911582STAK-CHEXStreck Laboratories, Inc.K902389TRI-COUNT 16Hematronix, Inc.K902391CELL-DYN 3000 CONTROLUnipath , Ltd.K901875PARA 12 PLUSStreck Laboratories, Inc.

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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