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Company · US

Esa Biosciences, Inc.

FDA 510(k) clearances and medical device recalls filed under this name, 2005 to 2008. Name variants (Inc, Corp, punctuation) are merged.

2510(k) clearances (0 in 12 months)

3recalls (0 in 12 months)

3recalls that name a 510(k)

Product codes

Code	Device	Records
DOF	Lead, Atomic Absorption	4
MRG	System, Test, Vitamin D	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
May 7, 2008	K072536	ESA BIOSCIENCES INC. VITAMIN D HPLC TEST Esa Biosciences, Inc.	MRG
Oct 6, 2005	K052549	LEADCARE II BLOOD LEAD TESTING SYSTEM Esa Biosciences, Inc.	DOF

Latest recalls

Date	Firm and product	Code	Linked 510(k)
Oct 18, 2007	Esa Biosciences, Inc. ESA LeadCare II Blood Test Kit, 6 test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-7142 Terminated	DOF	K052549
Oct 18, 2007	Esa Biosciences, Inc. ESA LeadCare II Blood Test Kit containing Level 1 and Level 2 Control Vials with lot number: 0704A Catalog Number: 70-6762 Terminated	DOF	K052549
Jun 21, 2005	Esa Biosciences, Inc. LeadCare Blood Lead Testing System Kits Catalog Number: 70-2233 Terminated	DOF	K971640

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