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510(k) Data Aggregation
K Number
K221839Device Name
Lancet
Manufacturer
Date Cleared
2022-09-19
(87 days)
Product Code
Regulation Number
878.4850Why did this record match?
Applicant Name (Manufacturer) :
Hebei Xinle Sci&Tech Co
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
It is intended for capillary blood sampling.
Device Description
The propose device, Lancet, which is intended for capillary blood sampling. The safety protection mechanism is to prevent the reuse of products and protection against needle stick injury. The proposed devices are provided sterile, single use. The proposed devices are divided into several models. In addition, the proposed devices are available in different specifications of needle gauge (21G, 28G and 30G) to allow to collect capillary blood sample.
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