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Company · GB

Dako Diagnostics , Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 1993 to 1998. Name variants (Inc, Corp, punctuation) are merged.

6510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
GNW	Antisera, Cf, Influenza Virus A, B, C	2
GQP	Antisera, Neutralization, Parainfluenza Virus 1-4	1
GQS	Antigens, Cf (Including Cf Control), Parainfluenza Virus 1-4	1
LIQ	Enzyme Linked Immunoabsorbent Assay, Rotavirus	1
LJC	Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)	1

Latest 510(k) clearances

Decided	510(k)	Device and applicant	Code
Sep 28, 1998	K981226	IMAGEARAINFLUENZA VIRUS GROUP (TYPES 1,2 AND 3) TEST AND IMAGEN PARAINFLUENZA VIRUS TEST TYPES 1,2 AND 3 Dako Diagnostics , Ltd., GB	GQP
Dec 22, 1997	K973954	IMAGEN RESPIRATORY SCREEN Dako Diagnostics , Ltd., GB	GNW
Dec 26, 1996	K962037	IMAGEN RESPIRATORY SCREEN Dako Diagnostics , Ltd., GB	GNW
Jan 11, 1996	K940564	IDEIA(TM) CHLAMYDIA BLOCKING REAGENTS, MODIFICATION Dako Diagnostics , Ltd., GB	LJC
Jan 9, 1995	K943557	IMAGEN Dako Diagnostics , Ltd., GB	GQS
Dec 27, 1993	K932384	IDEIA(TM) ROTAVIRUS Dako Diagnostics , Ltd., GB	LIQ

Latest recalls

Date	Firm and product	Code	Linked 510(k)
No recalls in this window.

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