Company ยท US
Syncor Intl. Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1983 to 1995. Name variants (Inc, Corp, punctuation) are merged.
31510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JHI | Visual, Pregnancy Hcg, Prescription Use | 4 |
| KXK | Source, Brachytherapy, Radionuclide | 3 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 2 |
| CKG | Radioimmunoassay, Acth | 2 |
| IWA | Source, Wire, Iridium, Radioactive | 2 |
| LJP | Antiserum, Fluorescent, Chlamydia Trachomatis | 2 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 1 |
| CDX | Radioimmunoassay, Total Thyroxine | 1 |
| CEE | Radioimmunoassay, Thyroxine-Binding Globulin | 1 |
| CEW | Radioimmunoassay, Parathyroid Hormone | 1 |
| CGC | Radioimmunoassay, Gastrin | 1 |
| ETD | Tube, Tympanostomy | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 |
| IXD | Source, Calibration, Sealed, Nuclear | 1 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 1 |
| JWZ | Kit, Screening, Trichomonas | 1 |
| KHQ | Radioassay, Triiodothyronine Uptake | 1 |
| KPY | Shield, Protective, Personnel | 1 |
| MOT | Irradiator, Blood To Prevent Graft Versus Host Disease | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 10, 1995 | K945825 | SECURE SAFETY INSERT Syncor Intl. Corp. | FMI |
| Sep 19, 1985 | K851828 | IRRADIATOR FOR BIOLOGICAL MATERIALS IBL-437-C Syncor Intl. Corp. | MOT |
| Aug 21, 1985 | K852023 | CESIUM 137 SOURCE, CSM-4, CSM-11, CSM-41 Syncor Intl. Corp. | KXK |
| Aug 21, 1985 | K850433 | CESIUM 137 ENDOMETRIAL SOURCE Syncor Intl. Corp. | KXK |
| Aug 13, 1985 | K852665 | SYNCOR TRICH DIRECT IMMUNOFLUORESCENCE ASSAY Syncor Intl. Corp. | JWZ |
| Jun 21, 1985 | K851033 | SYNCORTECH CHLAMYDIA DIRECT SPECIMAN KIT Syncor Intl. Corp. | LJP |
| Apr 29, 1985 | K844735 | PTH-RIA Syncor Intl. Corp. | CEW |
| Mar 26, 1985 | K850726 | WIRE CUTTERS, BRACHYTHERAPY-TABLE TOP & HAND HELD Syncor Intl. Corp. | IWA |
| Mar 26, 1985 | K850434 | CS137 SEALED SOURCES Syncor Intl. Corp. | KXK |
| Mar 26, 1985 | K850208 | FLOOD SOURCES & DOSE CALIBRATORS W/VARIOUS NUCLIDS Syncor Intl. Corp. | IXD |
| Mar 26, 1985 | K850163 | IRIDIUM 192 WIRES Syncor Intl. Corp. | IWA |
| Mar 1, 1985 | K850207 | PENPOINT, FLEXIBLE & SPOT MARKERS & RADOACTIVE RUL Syncor Intl. Corp. | |
| Jan 16, 1985 | K844582 | SYNCOR TECH CHLAMYDIA TISSUE CULTURE TEST Syncor Intl. Corp. | LJP |
| Dec 17, 1984 | K844160 | VENTIBOX Syncor Intl. Corp. | KPY |
| Nov 27, 1984 | K844181 | ACTH RIA Syncor Intl. Corp. | CKG |
| Sep 4, 1984 | K842445 | LH RIA Syncor Intl. Corp. | CEP |
| Aug 17, 1984 | K842444 | FSH RIA Syncor Intl. Corp. | CGJ |
| Jul 26, 1984 | K842598 | STAR HCG MONOCLONAL ANTIBODY IMMUNO Syncor Intl. Corp. | JHI |
| Jul 9, 1984 | K842167 | TBG RIA Syncor Intl. Corp. | CEE |
| Jun 25, 1984 | K841963 | GASTRIN RIA Syncor Intl. Corp. | CGC |
| Jun 25, 1984 | K841927 | T3 UPTAKE Syncor Intl. Corp. | KHQ |
| Jun 22, 1984 | K841854 | BHCG RIA Syncor Intl. Corp. | JHI |
| Mar 19, 1984 | K840127 | CURIETRON Syncor Intl. Corp. | JAQ |
| Mar 19, 1984 | K833851 | HCG RIA Syncor Intl. Corp. | JHI |
| Feb 4, 1984 | K833853 | T3 RIA Syncor Intl. Corp. | CDP |
| Jan 30, 1984 | K833849 | ACTH RIA Syncor Intl. Corp. | CKG |
| Jan 24, 1984 | K832796 | STAR HCG MONOCLONAL ANTIBODY IMMUNORAD Syncor Intl. Corp. | JHI |
| Jan 18, 1984 | K833850 | T4 RIA Syncor Intl. Corp. | CDX |
| Jan 13, 1984 | K833854 | LH RIA Syncor Intl. Corp. | CEP |
| Jan 13, 1984 | K833852 | FSH RIA Syncor Intl. Corp. | CGJ |
| Nov 22, 1983 | K833910 | TSH RIA Syncor Intl. Corp. | ETD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||