ClearanceBrief
Panels › Clinical Chemistry › Product code CGX · Class 2

Alkaline Picrate, Colorimetry, Creatinine

Regulation 862.1225

2510(k)s in 12 months (159 all time)
1recalls in 12 months (15 all time)
15recalls that name a 510(k)
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Top companies in CGX

Company510(k)sRecalls
Em Diagnostic Systems, Inc.100
Abbott Laboratories80
Harleco80
Siemens Healthcare Diagnostics, Inc.44
Beckman Coulter, Inc.42
Olympus Corp.60
Diagnostic Chemicals , Ltd.40
Pointe Scientific, Inc.,13
American Research Products Co.30
Amresco, Inc.30
Decided510(k)Device and applicantCode
Aug 22, 1977K771443MULTISTAT III CREATININE TEST
Instrumentation Laboratory CO
CGX
Aug 16, 1977K771365CREATININE ANALYSIS PRODUCTS
Abbott Laboratories
CGX
Aug 3, 1977K771335CREATININE ANALYZER 2
Beckman Instruments, Inc.
CGX
Jul 11, 1977K770819ULTRACHEM CREATININE
Harleco
CGX
Jun 24, 1977K770643CREATININE TEST, SUPER SEVENTEEN
Hycel, Inc.
CGX
May 3, 1977K770454CREATININE PROCEDURE, TEKPOINT
Icn Pharmaceuticals, Inc.
CGX
Feb 22, 1977K770242REAGENT SYSTEM
American Monitor Corp.
CGX
Feb 14, 1977K761280AUTO CREATININE REAGENT (GILFORD 3400-E)
Harleco
CGX
Feb 11, 1977K761279AUTO CREATININE REAGENT (ABBOTT SYSTEM)
Harleco
CGX

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