Panels › Clinical Chemistry › Product code CEC · Class 2
Radioimmunoassay, Free Thyroxine
Regulation 862.1695
0510(k)s in 12 months (92 all time)
0recalls in 12 months (13 all time)
13recalls that name a 510(k)
Top companies in CEC
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Laboratories | 8 | 0 |
| Bd Becton Dickinson Vacutainer Systems Preanalytic | 8 | 0 |
| Siemens Healthcare Diagnostics | 5 | 2 |
| Amersham Corp. | 5 | 0 |
| Beckman Coulter, Inc. | 1 | 4 |
| Abbott Laboratories HPD/ADD | 0 | 3 |
| Corning Medical & Scientific | 3 | 0 |
| Diagnostic Products Corp. | 3 | 0 |
| Roche Diagnostics | 3 | 0 |
| Advanced Magnetics, Inc. | 2 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 10, 1992 | K922284 | ELEGANCE FT4 ELISA Bioclone Australia Pty , Ltd. | CEC |
| Mar 2, 1992 | K920247 | AMERLITE MAB FT4 ASSAY Eastman Kodak Company | CEC |
| Dec 17, 1991 | K914835 | LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY London Diagnostics, Inc. | CEC |
| Nov 19, 1991 | K912937 | SR1 FREE T4 ENZYME IMMUNOASSAY Serono-Baker Diagnostics, Inc. | CEC |
| Oct 7, 1991 | K912698 | AFFINITY FREE T4 TEST SYSTEM Bd Becton Dickinson Vacutainer Systems Preanalytic | CEC |
| Sep 10, 1991 | K913493 | AIA-PACK FT4 Tosoh Corp. | CEC |
| Jun 24, 1991 | K911634 | MICROZYME(TM) FREE T4 ENZYME IMMUNOASSAY TEST Immunotech Corp. | CEC |
| May 1, 1991 | K910684 | CIBA CORNING ACS FT4 IMMUNOASSAY Ciba Corning Diagnostics Corp. | CEC |
| Nov 30, 1990 | K904539 | FLAGEN TM FREE T4 Cyberfluor, Inc., CA | CEC |
| Sep 10, 1990 | K903384 | IMX FREE T4 CALCULATION Abbott Laboratories | CEC |
| Sep 10, 1990 | K903383 | TDX FREE T4 CALCULATION Abbott Laboratories | CEC |
| Sep 7, 1990 | K902834 | ABBOTT IMX FREE T4 Abbott Laboratories | CEC |
| May 15, 1990 | K900883 | ENZYMUN TEST(R) FT4 (FREE THYROXINE) Boehringer Mannheim Corp. | CEC |
| Mar 29, 1990 | K900060 | FREE T4 IMMUNOASSAY KIT Advanced Magnetics, Inc. | CEC |
| Nov 17, 1989 | K896222 | FREE THYROXINE (FT4) RADIOIMMUNOASSAY KIT Nichols Institute Diagnostics | CEC |
| Sep 18, 1989 | K894605 | DELFIA FREE THYROXINE (FT4) KIT Pharmacia, Inc. | CEC |
| Aug 3, 1989 | K894091 | AMERLEX-MAB FT4 KIT Amersham Corp. | CEC |
| Feb 27, 1989 | K884753 | MODIFIED FREE T4 RADIOIMMUNOASSAY KIT Advanced Magnetics, Inc. | CEC |
| Dec 22, 1988 | K883123 | AMERLIITE FT4 ASSAY LAN.0006/2006 240/144 TEST KIT Amersham Corp. | CEC |
| Oct 25, 1988 | K883971 | QLIA T UPTAKE ASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic | CEC |
| Mar 24, 1988 | K874875 | CHEMELIA FREE THYROXINE(FT4)/ENZYME IMMUNO. (EIA) Boots-Celltech Diagnostics, Inc. | CEC |
| Sep 14, 1987 | K870268 | DIAGNOSTIC KIT FREE T3 AND FREE T4 Sclavo, Inc. | CEC |
| Mar 19, 1987 | K870158 | STRATUS FREE THYROXINE (FT4) FLUOR. ENZYME IMMUNO. American Dade | CEC |
| Mar 16, 1987 | K865104 | IQ FTI IMMUNOASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic | CEC |
| Mar 12, 1987 | K864658 | IQ FREE T4 IMMUNOASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic | CEC |
| Feb 18, 1987 | K864838 | SIMULTRAC FREE T4[57CO]/TSH MAB[125I] Bd Becton Dickinson Vacutainer Systems Preanalytic | CEC |
| Feb 11, 1986 | K860251 | AMERLEX-M T4 RIA KIT FOR SERUM AND PLASMA Amersham Corp. | CEC |
| Sep 18, 1985 | K853628 | SIMULTRAC FREE T4(57CO)/TSH[125I] RADIOIMMUNOASSAY Bd Becton Dickinson Vacutainer Systems Preanalytic | CEC |
| Aug 10, 1984 | K842482 | AMERLEX-M FREE T-4 RADIOIMMUNOASSAY KIT Amersham Corp. | CEC |
| Apr 25, 1984 | K840901 | PHASE II FREE T4 KIT Medical & Scientific Designs, Inc. | CEC |
| Sep 1, 1983 | K832381 | CORNING MAGIC SINGLE STEP FREE T4 Corning Medical & Scientific | CEC |
| Jan 12, 1983 | K823264 | THYROXINE ANALYSIS PRODUCTS/RADIO-FREE Bd Becton Dickinson Vacutainer Systems Preanalytic | CEC |
| Dec 15, 1982 | K823005 | BIO MAG FREE T4 RADIOIMMUNOASSAY KIT Bioclinical Group | CEC |
| Nov 29, 1982 | K823144 | SINGLE STEP FREE-T4 125I RADIOIMMUNO- Corning Medical & Scientific | CEC |
| Nov 5, 1982 | K822882 | COAT-A-COUNT FREE THYROXINE KIT/COMPONEN Diagnostic Products Corp. | CEC |
| Jun 1, 1982 | K821241 | FREE T4 RADIOIMMUNOASSAY KIT Bioclinical Group | CEC |
| Dec 31, 1981 | K813465 | FREE T4 RIA TEST SET Ventrex Laboratories, Inc. | CEC |
| Feb 10, 1981 | K810231 | CODE IM 2050 AMERLEX FREE T4 RIA KIT Amersham Corp. | CEC |
| Oct 17, 1978 | K781560 | RIA DIAG. TEST KIT FOR INDEXING THYROX. Nuclear Diagnostics, Inc. | CEC |
| Jul 27, 1978 | K781012 | RIA TEST KIT SYS. DAMON KIQUISOL FREE Damon Corp. | CEC |
| Jan 6, 1978 | K772194 | IMMO PHASE FT4 ASSAY Corning Medical & Scientific | CEC |
| Aug 3, 1977 | K771236 | TRIOBEAD-125 DIAGNOSTIC KIT Abbott Laboratories | CEC |
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