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FDA 510(k)

CHEMMATE(TM) UCHL1 (CD45-RO)

K-Number: K950152 · 1995-10-27

ApplicantBiotek Solutions, Inc.
Decision Date1995-10-27
Product CodeDFH
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

CHEMMATE(TM) UCHL1 (CD45-RO) 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 1995-10-27 under 510(k) number K950152. The device is classified under product code DFH. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CHEMMATE(TM) UCHL1 (CD45-RO)?

CHEMMATE(TM) UCHL1 (CD45-RO) is a medical device that received FDA 510(k) clearance on 1995-10-27. The listed applicant is Biotek Solutions, Inc.. The 510(k) number is K950152.

When did CHEMMATE(TM) UCHL1 (CD45-RO) receive FDA 510(k) clearance?

CHEMMATE(TM) UCHL1 (CD45-RO) received FDA 510(k) clearance on 1995-10-27, under 510(k) number K950152.

Who is the listed applicant for CHEMMATE(TM) UCHL1 (CD45-RO)?

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) UCHL1 (CD45-RO)?

The FDA product code for CHEMMATE(TM) UCHL1 (CD45-RO) is DFH.

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.

K950148CHEMMATE(TM) CD43K936111CHEMMATE SPECIAL STAIN LCA-CD45K950149CHEMMATE(TM) LAMBDAK950150CHEMMATE(TM) KAPPAK950151CHEMMATE(TM) L26 (CD20)

Related Devices (Code: DFH)

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.

K253358Diazyme Human Kappa (k) Free Light Chain Assay; Diazyme Human Lambda (¿) Free Light Chain AssayDiazyme Laboratories, Inc.K250549Optilite® Freelite Mx Kappa Free Kit; Optilite® Freelite Mx Lambda Free KitThe Binding Site Group , Ltd.K231601FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2SebiaK231290Optilite® Freelite® Kappa Free Kit, Optilite® Freelite® Lambda Free KitThe Binding Site, Ltd.K210623FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2SebiaK211648Diazyme Human Kappa Free Light Chain Assay, Diazyme Human Lambda Free Light Chain AssayDiazyme Laboratories, Inc.

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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