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FDA 510(k)

CHEMMATE(TM) CD43

K-Number: K950148 · 1996-07-02

ApplicantBiotek Solutions, Inc.
Decision Date1996-07-02
Product CodeDEH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CHEMMATE(TM) CD43 is the device name listed in this FDA 510(k) record. The listed applicant is Biotek Solutions, Inc.. It received FDA 510(k) clearance on 1996-07-02 under 510(k) number K950148. The device is classified under product code DEH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMMATE(TM) CD43?

CHEMMATE(TM) CD43 is a medical device that received FDA 510(k) clearance on 1996-07-02. The listed applicant is Biotek Solutions, Inc.. The 510(k) number is K950148.

When did CHEMMATE(TM) CD43 receive FDA 510(k) clearance?

CHEMMATE(TM) CD43 received FDA 510(k) clearance on 1996-07-02, under 510(k) number K950148.

Who is the listed applicant for CHEMMATE(TM) CD43?

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

What is the FDA product code for CHEMMATE(TM) CD43?

The FDA product code for CHEMMATE(TM) CD43 is DEH.

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Biotek Solutions, 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.

K936111CHEMMATE SPECIAL STAIN LCA-CD45K950149CHEMMATE(TM) LAMBDAK950152CHEMMATE(TM) UCHL1 (CD45-RO)K950150CHEMMATE(TM) KAPPAK950151CHEMMATE(TM) L26 (CD20)

Related Devices (Code: DEH)

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.

K172471VENTANA CD30 (Ber-H2) RxDx AssayVentana Medical Systems, Inc.K083601LAMBDA LIGHT CHAINSSENTINEL CH. SpAK033811FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE OLYMPUS AU ANALYZERThe Binding Site, Ltd.K031016FREELITE HUMAN KAPPA AND LAMBDA FREE KITS FOR USE ON THE DAD BEHRING NEPHELOMETER IIThe Binding Site, Ltd.K023131FREELITE HUMAN LAMBDA FREE KITThe Binding Site, Ltd.K010440FREELITE LAMBDA FREE KITThe Binding Site, Ltd.

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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