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

Acid, Folic, Radioimmunoassay

Regulation 862.1295

0510(k)s in 12 months (64 all time)
0recalls in 12 months (41 all time)
37recalls that name a 510(k)
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Top companies in CGN

Company510(k)sRecalls
Siemens Healthcare Diagnostics, Inc.116
Abbott Laboratories HPD/ADD/GPRD013
Abbott Laboratories53
Beckman Coulter, Inc.53
Roche Diagnostics71
Bio-Rad50
Diagnostic Products Corp.40
Ortho-Clinical Diagnostics, Inc.22
Clinical Assays, Inc.30
Microgenics Corp.30
Decided510(k)Device and applicantCode
Feb 4, 1981K810186MICROMEDIC SYSTEMS' AUTOPAK
Micromedic Systems
CGN
Jan 16, 1981K810001'NO-BOIL' DUALCOUNT KIT
Diagnostic Products Corp.
CGN
Dec 22, 1980K803060FOLATE 125I RADIOIMMUNOASSAY
Corning Medical & Scientific
CGN
Jul 21, 1980K801198FOLATE RADIOASSAY KIT
Calbiochem-Behring Corp.
CGN
May 8, 1980K800914NO-BOIL FOLATE KIT #RP-500
Ria Products, Inc.
CGN
Nov 13, 1979K792167125 I FOLATE SOLID PHASE RADIOASSAY
Abbott Laboratories
CGN
Jul 17, 1979K791079GAMMADAB (125 1) FOLATE RADIOASSAY KIT
Clinical Assays, Inc.
CGN
May 18, 1978K780557FOLATE REAGENT KIT, ARIA-II SYSTEM
Bd Becton Dickinson Vacutainer Systems Preanalytic
CGN
May 3, 1978K780508QUANTITOPE 125I-FOLATE RADIOASSAY KIT
Kallestad Laboratories, Inc.
CGN
Mar 3, 1978K780148RIA FOR FOLATES & VIT. B12, COMBO KIT
Ria Products, Inc.
CGN
Sep 13, 1977K771597IN VITRO FOLATE RADIOASSAY KIT
Clinical Assays, Inc.
CGN
Aug 3, 1976K760262RADIOASSY KIT, 3H-FOLATE
Diamond Shamrock Corp.
CGN
Jul 26, 1976K760207KIT, FOLATE RADIOASSAY SC.7
Amersham Corp.
CGN
Jul 20, 1976K760133PROCEDURE, RED CELL FOLATE ASSAY
Bio-Rad
CGN

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