Panels › Immunology › Product code JZO · Class 2
System, Test, Thyroid Autoantibody
Regulation 866.5870
0510(k)s in 12 months (92 all time)
1recalls in 12 months (18 all time)
17recalls that name a 510(k)
Top companies in JZO
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 7, 1998 | K981559 | UNICAP THYROGLOBULIN IGG ASSAY, UNICAP THYROID PEROXIDASE IGG ASSAY Pharmacia & Upjohn Co. | JZO |
| May 1, 1998 | K980206 | IMMULITE ANTI-TG AB Diagnostic Products Corp. | JZO |
| Jul 14, 1997 | K972190 | THYROGLOBULIN ASSAY SYSTEM American Laboratory Products Co., Ltd. | JZO |
| Jan 17, 1997 | K963695 | IMMULITE ANTI-TPO-AB(LKTOI,LKT05,LKTOZ Diagnostic Products Corp. | JZO |
| Jun 20, 1996 | K960370 | THYROGLOBULIN ANTIBODY ELISA Immco Diagnostics, Inc. | JZO |
| Jun 20, 1996 | K960369 | THYROID PEROXIDASE ANTIBODY ELISA Immco Diagnostics, Inc. | JZO |
| Jun 30, 1995 | K952183 | DIASTAT ANTI-THYROGLOBULIN KIT Shield Diagnostics, Ltd., GB | JZO |
| Jun 30, 1995 | K951487 | DIASTAT ANTI-THYROID PEROXIDASE KIT Shield Diagnostics, Ltd., GB | JZO |
| Jun 20, 1995 | K952130 | ORGENTEC ANTI-TG ELISA American Laboratory Products Co., Ltd. | JZO |
| Jun 20, 1995 | K952129 | ORGENTEC ANTI-TPO ELISA American Laboratory Products Co., Ltd. | JZO |
| Apr 24, 1995 | K950217 | ORGENTEC THYROGLOBULIN PIA (PIN IMMUNO ASSAY) American Laboratory Products Co., Ltd. | JZO |
| Apr 21, 1995 | K950090 | ORGENTEC ANTI-TPO PIA (PIN IMMUNO ASSAY) American Laboratory Products Co., Ltd. | JZO |
| Apr 21, 1995 | K950089 | ORGENTEC ANTI-TG PIA (PIN IMMUNO ASSAY) American Laboratory Products Co., Ltd. | JZO |
| Apr 21, 1995 | K950088 | ORGENTEC ANTI-TG/ANTI-TPO PIA (PIN IMMUNO ASSAY) American Laboratory Products Co., Ltd. | JZO |
| May 14, 1993 | K931311 | THYROID PEROXIDASE AUTO ANTIBODIES(TPO) IMMUN KIT Nichols Institute | JZO |
| Mar 16, 1993 | K930485 | QUANTA LITE(TM) THYROID M ELISA Inova Diagnostics, Inc. | JZO |
| Feb 23, 1993 | K930274 | THYROID MICROSOMAL ANTIGEN AUTO-ANTIBODY ENZYME Joldon Diagnostics, CA | JZO |
| Feb 5, 1993 | K925194 | THYROGLOBULIN AUTO-ANTIBODY EIA TEST KIT Joldon Diagnostics, CA | JZO |
| Jan 26, 1993 | K925826 | ENCORE THYROGLOBULIN IGE, IGA AND IGM EIA Clark Laboratories, Inc. | JZO |
| Jan 21, 1993 | K925785 | AUTOSTAT ANTI-THYROID MICROSOMAL KIT Cogent Diagnotics , Ltd., GB | JZO |
| Jan 21, 1993 | K925784 | AUTOSTAT ANTITHYROGLOBIN Cogent Diagnotics , Ltd., GB | JZO |
| Jan 14, 1993 | K925923 | ELIAS TMAB Elias U.S.A., Inc. | JZO |
| Jan 14, 1993 | K925922 | ELIAS TGAB Elias U.S.A., Inc. | JZO |
| Apr 8, 1992 | K915135 | SYNELISA TGAB/TMAB Elias U.S.A., Inc. | JZO |
| Apr 8, 1992 | K915134 | SYNELISA TGAB Elias U.S.A., Inc. | JZO |
| Apr 8, 1992 | K915133 | SYNELISA TMAB Elias U.S.A., Inc. | JZO |
| Mar 30, 1992 | K915429 | KRONUS KALIBRE THYROID PEROXIDASE ANTIBODY EIA KIT Kronus | JZO |
| Mar 30, 1992 | K915428 | KRONUS KALIBRE THYROGLOBULIN ANTIBODY EIA KIT Kronus | JZO |
| Jan 25, 1991 | K905485 | IMMUNOWELL THYROGLOBULIN TEST General Biometrics, Inc. | JZO |
| Oct 15, 1990 | K904224 | NOVA LITE TM THYROID Inova Diagnostics, Inc. | JZO |
| Jul 25, 1989 | K894364 | MODIFIED KRONUS TEST KIT FOR ANTIBODIES TO (TPO) Kronus | JZO |
| Jul 25, 1989 | K894203 | ANTI-THYROGLOBULIN TEST KIT Kronus | JZO |
| Jun 6, 1988 | K881933 | KALLESTAD QUANTAFLUOR ANTITHYROID ANTIBODY TEST Kallestad Diag, A Div. of Erbamont, Inc. | JZO |
| May 15, 1987 | K871193 | I-125 ANTI-THYROGLOBULIN ANTIBODY IRMA TEST KIT Cronus | JZO |
| Feb 18, 1987 | K865053 | SERA-TEK MICROSOMAL ANTIBODY TEST Miles Laboratories, Inc. | JZO |
| Sep 8, 1986 | K863006 | 125-I TSH RECEPTOR ANTIBODY KIT Cronus | JZO |
| Oct 22, 1984 | K843343 | MEDICA IIF-ANTI-THYROID ANTIBODY TEST Medical Diagnostics, Ca. | JZO |
| Oct 22, 1984 | K841580 | TSH RECEPTOR ANTIBODY KIT 125I TSH Clinetics Corp. | JZO |
| Jun 9, 1982 | K821489 | CORDIA TG Cordis Corp. | JZO |
| May 1, 1981 | K810982 | ANTITHYROID ANTIBODY IMMUNOFLUORESCENT Immuno-Products Industries | JZO |
| Dec 31, 1979 | K791458 | AGGLUTINOTEST-THYROGLOBULIN Volu Sol Medical Industries | JZO |
| Jul 20, 1976 | K760154 | TEST, (IVDP) THYROID ANTIBODY Zeus Scientific, Inc. | JZO |
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