Panels › Clinical Chemistry › Product code CDZ · Class 1
Radioimmunoassay, Testosterones And Dihydrotestosterone
Regulation 862.1680
1510(k)s in 12 months (89 all time)
2recalls in 12 months (19 all time)
17recalls that name a 510(k)
Top companies in CDZ
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 6, 1994 | K940449 | DELFIA SHBG KIT Wallac OY, FI | CDZ |
| Dec 10, 1993 | K934562 | CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY Ciba Corning Diagnostics Corp. | CDZ |
| Aug 3, 1993 | K932951 | DELFIA TESTTOSTERONE KIT Wallac OY, FI | CDZ |
| Nov 30, 1992 | K924257 | TESTOSTERONE SEROZYME(TM) ENZYME IMMUNOASSAY Serono-Baker Diagnostics, Inc. | CDZ |
| Mar 17, 1992 | K915823 | DSL ACTIVE SHBG (DSL 7400) Diagnostic Systems Laboratories, Inc. | CDZ |
| Mar 2, 1992 | K915164 | SRI TESTOSTERONE ENZYME IMMUNOASSAY Serono-Baker Diagnostics, Inc. | CDZ |
| Jan 27, 1992 | K915570 | GAMMA COAT ASSAY TESTOSTERONE RADIOIMMUNOASSAY KIT Incstar Corp. | CDZ |
| Aug 12, 1991 | K912850 | SHBG Wien Laboratories, Inc. | CDZ |
| Jan 17, 1991 | K905247 | SHBG IRMA KIT Ventrex Laboratories, Inc. | CDZ |
| Oct 15, 1990 | K904100 | DSL SEX HORMONE BINDING GLOBULIN (SHBG) (DSL 6300) Diagnostic Systems Laboratories, Inc. | CDZ |
| Mar 8, 1989 | K884809 | DELFIA SHBG KIT Pharmacia, Inc. | CDZ |
| Oct 31, 1988 | K883267 | IRMA-COUNT (TM) SHBG (SEX HORMORNE BIND GLOBULIN) Diagnostic Products Corp. | CDZ |
| Mar 13, 1987 | K861679 | SHBG IRMA KIT Farmos Group , Ltd. | CDZ |
| Jan 14, 1987 | K862483 | PANTEX FTE FREE TESTOSTERONE RADIOIMMUNOASSAY KIT Pantex, Div. Bio-Analysis, Inc. | CDZ |
| Mar 17, 1986 | K860003 | LEECO TESTOSTERONE DIAGNOSTIC KIT Leeco Diagnostics, Inc. | CDZ |
| Feb 19, 1986 | K860130 | TESTOSTERONE COATED TUBES RADIOIMMUNOASSAY KIT Cambridge Medical Technology | CDZ |
| Dec 19, 1985 | K854674 | DSL ANDROSTENDIONE RIA (DSL #4200) Diagnostic Systems Laboratories, Inc. | CDZ |
| Dec 19, 1985 | K854671 | DSL ACTIVE TESTOSTERONE RIA (DSL #4000) Diagnostic Systems Laboratories, Inc. | CDZ |
| Oct 15, 1985 | K853865 | PANTEX DIRECT TESTOSTERONE COATED TUBE RADIOIMMUNO Pantex, Div. Bio-Analysis, Inc. | CDZ |
| Feb 27, 1985 | K844423 | COAT-A-COUNT FREE TESTOSTERONE KIT & COMPONENTS Diagnostic Products Corp. | CDZ |
| Jun 25, 1984 | K841948 | TESTOSTERONE DIRECT RADIOIMMUNOASSAY Sorin Biomedica, Fiat, USA, Inc. | CDZ |
| Apr 19, 1984 | K841042 | MATCHED COMPONENT SET RADIOIMMUNOASSAY Cambridge Medical Technology | CDZ |
| Mar 23, 1984 | K840187 | IMMOPHASE DTESTO RADIOIMMUNOASSAY- Corning Medical & Scientific | CDZ |
| Jun 2, 1983 | K831342 | COAT-A-COUNT NO-EXTRACTION TESTOSTERONE Diagnostic Products Corp. | CDZ |
| Apr 5, 1983 | K830512 | LEECO TESTOSTERONE DIAGNOSTIC KIT Leeco Diagnostics, Inc. | CDZ |
| Dec 22, 1981 | K813401 | COAT-A-COUNT TESTOSTERONE RIA KIT Diagnostic Products Corp. | CDZ |
| Nov 16, 1981 | K813059 | LEECO TESTO-QUANT DIAG. KIT Leeco Diagnostics, Inc. | CDZ |
| Jun 18, 1981 | K811536 | DIRECT TESTOSTERONE RIA Immuchem Corp. | CDZ |
| Jan 2, 1981 | K803001 | LEECO TESTO-QUANT DIAGNOSTIC KIT Leeco Diagnostics, Inc. | CDZ |
| Dec 11, 1980 | K802728 | 125I-TESTOSTERONE TEST SET Wien Laboratories, Inc. | CDZ |
| Dec 10, 1980 | K802661 | LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT Damon Corp. | CDZ |
| Oct 10, 1980 | K802135 | TESTOSTERONE RADIOIMMUNOASSY KIT Radioimmunoassay, Inc. | CDZ |
| Aug 27, 1980 | K801666 | TESTOSTERONE KIT Immuchem Corp. | CDZ |
| May 14, 1980 | K800921 | NORDICLAB TESTOSTERONE RIA TEST Nordiclab Intl. | CDZ |
| Apr 21, 1980 | K800776 | TESTOK-125 Sorin Biomedica, Fiat, USA, Inc. | CDZ |
| Oct 30, 1979 | K791999 | (125I) TESTOSTERONE KIT Radioassay Systems Laboratories, Inc. | CDZ |
| Feb 26, 1979 | K790007 | I TESTOTERONE Cambridge Nuclear Corp. | CDZ |
| Jun 13, 1978 | K780792 | TESTOSTERONE RADIOIMMUNOASSAY KIT 125I The Upjohn Co. | CDZ |
| Jan 12, 1978 | K772191 | TESTOSTERONE RIA KIT (125I) Diagnostic Products Corp. | CDZ |
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