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Panels › Clinical Chemistry › Product code CEK · Class 2

Biuret (Colorimetric), Total Protein

Regulation 862.1635

0510(k)s in 12 months (116 all time)
0recalls in 12 months (10 all time)
1recalls that name a 510(k)
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Top companies in CEK

Company510(k)sRecalls
Em Diagnostic Systems, Inc.100
Harleco60
Siemens Healthcare Diagnostics, Inc.06
Beckman Instruments, Inc.40
Data Medical Associates, Inc.40
Ortho Clinical Diagnostics Inc04
Medical Analysis Systems, Inc.30
Wako Chemicals USA, Inc.30
Abbott Laboratories20
American Monitor Corp.20
Decided510(k)Device and applicantCode
Dec 6, 1979K792346TWO MINUTE PROTEINTEST
Panmed, Inc.
CEK
Dec 6, 1979K792340CONNECT. DIAG. TOTAL PROTEIN DIAG. REAGE
Connecticut Diagnostics, Ltd.
CEK
Nov 13, 1979K792138SMAC (SEQUENTIAL MULT. ANALYSIS COMP.
Fisher Scientific Co., LLC
CEK
Nov 5, 1979K790808PROTEIN ASSAY KIT
Specialty Medical Industries, Inc.
CEK
Jan 10, 1979K781897STAT KIT, MICROPROTEIN
Pierce Chemical Co.
CEK
Nov 22, 1978K781774TOTAL PROTEIN
Gilford Diagnostics
CEK
Nov 3, 1978K781722REAGENT SET, TOTAL PROTEIN
Medical Analysis Systems, Inc.
CEK
Dec 6, 1977K772155ULTRACHEM TOTAL PROTEIN, #64974
Harleco
CEK
Nov 11, 1977K771926TOTAL PROTEIN SET, ITEM NO. 64010
Harleco
CEK
Oct 25, 1977K771841TOTAL PROTEIN
Gamma Enterprises, Inc.
CEK
Sep 12, 1977K771476MULTISTAT III TOTAL PROTEIN TEST
Instrumentation Laboratory CO
CEK
Jul 14, 1977K770887AUTO TOTAL PROTEIN FOR ANALYZER
Harleco
CEK
May 3, 1977K770452PROTEIN PROCEDURE, TEKPOINT TOTAL
Icn Pharmaceuticals, Inc.
CEK
Dec 21, 1976K761257AUTO TOTAL PROTEIN
Harleco
CEK
Dec 21, 1976K761217AUTO TOTAL PROTEIN
Harleco
CEK
Oct 29, 1976K760480REAGENT, TOTAL PROTEIN DETERMINATION
Simmler & Son, Inc.
CEK

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