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Panels › Clinical Chemistry › Product code CED · Class 1

5-Amp-Phosphate Release (Colorimetric Test), 5'-Nucleotidase

Regulation 862.1520

0510(k)s in 12 months (9 all time)

0recalls in 12 months (0 all time)

0recalls that name a 510(k)

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Top companies in CED

Company	510(k)s	Recalls
Union Carbide Corp.	2	0
American Monitor Corp.	1	0
Btc Diagnostics, Inc.	1	0
Connecticut Diagnostics, Ltd.	1	0
Eastman Kodak Company	1	0
Em Diagnostic Systems, Inc.	1	0
Sandare Chemical Co., Inc.	1	0
Sigma Chemical Co.	1	0

Decided	510(k)	Device and applicant	Code
Aug 31, 1989	K894288	PHOSPHORUS TEST ITEM NUMBER 65416 Em Diagnostic Systems, Inc.	CED
Mar 22, 1984	K840151	EKTACHEM CLINICAL CHEM. SLIDES Eastman Kodak Company	CED
Jan 30, 1984	K833710	BTC URINE LH ASSAY Btc Diagnostics, Inc.	CED
Apr 15, 1982	K820832	PHOSPHORUS IL American Monitor Corp.	CED
Oct 2, 1981	K812670	SANDARE FAST 340 PHOSPHORUS PROCEDURE Sandare Chemical Co., Inc.	CED
Jul 31, 1981	K811864	SIGMA PROCEDURE 265-UV Sigma Chemical Co.	CED
May 21, 1981	K811222	INORGANIC PHOSPHORUS REAGENTS Connecticut Diagnostics, Ltd.	CED
Oct 31, 1980	K802420	CENTRIFICHEM INORGANIC PHOSPHORUS Union Carbide Corp.	CED
May 15, 1979	K790662	CENTRIFICHEM INORGANIC PHOSPHORUS Union Carbide Corp.	CED

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