Company · US

Direct Solutions

FDA 510(k) clearances and medical device recalls filed under this name, 1995 to 1996. Name variants (Inc, Corp, punctuation) are merged.

5510(k) clearances (0 in 12 months)

0recalls (0 in 12 months)

0recalls that name a 510(k)

Product codes

Code	Device	Records
GGM	Control, Hemoglobin	2
JJX	Single (Specified) Analyte Controls (Assayed And Unassayed)	2
JJS	Controls For Blood-Gases, (Assayed And Unassayed)	1

Decided	510(k)	Device and applicant	Code
Nov 8, 1996	K963909	HEMOCUE GLUCOLIN Direct Solutions	JJX
Nov 6, 1996	K964052	HEMOCUE HEMOTROL Direct Solutions	GGM
Nov 1, 1996	K964053	HEMOCUE GLUCOTROL Direct Solutions	JJX
Oct 16, 1996	K963908	HEMOCUE HEMOLIN Direct Solutions	GGM
Dec 26, 1995	K955340	EUROTROL GAS - ISE CONTROL Direct Solutions	JJS

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