HLB Receives FDA Approval for Its Micro Blood Collection Device, the Lancet.

The Lancet product recently received 510(k) clearance from the FDA by HLB.

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Biotech company HLB announced on the 21st that its micro blood collection device, the ‘lancet,’ has received FDA approval for medical device sales.

 

The lancet is a small, short needle encased in a plastic housing, commonly used by diabetes patients for blood glucose monitoring or for blood collection in various diagnostic tests.

 

HLB explained that after establishing a manufacturing facility for the lancet early last year, the company obtained GMP (Good Manufacturing Practice) certification from the Korean Ministry of Food and Drug Safety in October and completed product registration. In November, HLB submitted a 510(k) application to the FDA for medical device sales approval and recently received notification of clearance.

 

HLB plans to enter the U.S. market by supplying lancets to its existing partner, a global healthcare company. Simultaneously, the company aims to target the Indian market, which boasts a population of 1.45 billion.