Company ยท US
Ciba Corning Diagnostics Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 1996. Name variants (Inc, Corp, punctuation) are merged.
125510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| JJY | Multi-Analyte Controls, All Kinds (Assayed) | 13 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 7 |
| DHB | System, Test, Radioallergosorbent (Rast) Immunological | 7 |
| JJE | Analyzer, Chemistry (Photometric, Discrete), For Clinical Use | 7 |
| CDD | Radioassay, Vitamin B12 | 4 |
| JGS | Electrode, Ion Specific, Sodium | 4 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 4 |
| CDX | Radioimmunoassay, Total Thyroxine | 3 |
| CEP | Radioimmunoassay, Luteinizing Hormone | 3 |
| JHI | Visual, Pregnancy Hcg, Prescription Use | 3 |
| KHQ | Radioassay, Triiodothyronine Uptake | 3 |
| LJC | Enzyme Linked Immunoabsorbent Assay, (Chlamydiae Group) | 3 |
| CDP | Radioimmunoassay, Total Triiodothyronine | 2 |
| CEC | Radioimmunoassay, Free Thyroxine | 2 |
| CFT | Radioimmunoassay, Prolactin (Lactogen) | 2 |
| CGJ | Radioimmunoassay, Follicle-Stimulating Hormone | 2 |
| CGN | Acid, Folic, Radioimmunoassay | 2 |
| CHP | Radioimmunoassay, Estradiol | 2 |
| DBF | Ferritin, Antigen, Antiserum, Control | 2 |
| DGC | Ige, Antigen, Antiserum, Control | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 5, 1996 | K962559 | ACS CORTISOL IMMUNOASSAY Ciba Corning Diagnostics Corp. | JFT |
| Oct 15, 1996 | K963251 | CIBA CORNING ACS;180 DPD ASSAY Ciba Corning Diagnostics Corp. | JMM |
| Jul 26, 1996 | K961807 | CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 Ciba Corning Diagnostics Corp. | GLK |
| Jun 25, 1996 | K961657 | CIBA CORNING 400 SYSTEM Ciba Corning Diagnostics Corp. | CHL |
| Jun 24, 1996 | K962021 | CIBA CORNING 348 SYSTEM Ciba Corning Diagnostics Corp. | CHL |
| Jun 21, 1996 | K962126 | ACS CKMB II IMMUNOASSAY Ciba Corning Diagnostics Corp. | JHS |
| Jun 21, 1996 | K962041 | ACS LH2 IMMUNOASSAY Ciba Corning Diagnostics Corp. | CEP |
| Jun 17, 1996 | K961510 | ACS FRT4 IMMUNOASSAY Ciba Corning Diagnostics Corp. | JJX |
| Apr 23, 1996 | K960246 | LIQUID CARDIAC MARKER 1,2,3 ASSAYED Ciba Corning Diagnostics Corp. | JJT |
| Mar 11, 1996 | K955873 | ACS PHENYTOIN ASSAY Ciba Corning Diagnostics Corp. | LGR |
| Dec 13, 1995 | K954697 | CIBA CORNING ACS ESTRADIOL-6 ASSAY Ciba Corning Diagnostics Corp. | CHP |
| Dec 11, 1995 | K953021 | ACS PHENOBARBITAL Ciba Corning Diagnostics Corp. | DIS |
| Aug 2, 1995 | K953020 | ACS GENTAMICIN Ciba Corning Diagnostics Corp. | LCD |
| Jun 20, 1995 | K951169 | CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY Ciba Corning Diagnostics Corp. | LGS |
| Jun 19, 1995 | K951059 | CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY Ciba Corning Diagnostics Corp. | LEH |
| Jun 13, 1995 | K951796 | CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOASSAY Ciba Corning Diagnostics Corp. | JLW |
| May 5, 1995 | K945367 | CIBA CORNING ACS CORTISOL IMMUNOASSAY Ciba Corning Diagnostics Corp. | CGR |
| Jan 30, 1995 | K946224 | CERTAIN(R) ELITE LEVEL 1, 2 AND 3 Ciba Corning Diagnostics Corp. | JJS |
| Jan 30, 1995 | K946206 | CIBA CORNING 8-- SERIES CO-OXIMETER Ciba Corning Diagnostics Corp. | CHL |
| Dec 12, 1994 | K943297 | CIBA CORNING ACS FOLATE ASSAY Ciba Corning Diagnostics Corp. | CGN |
| Aug 1, 1994 | K935228 | MODEL 644 SWEAT DILUENT Ciba Corning Diagnostics Corp. | CGZ |
| May 23, 1994 | K940810 | CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF Ciba Corning Diagnostics Corp. | JJE |
| May 13, 1994 | K934317 | CIDBA CORNING ACS CORTISOL IMMUNOASSAY Ciba Corning Diagnostics Corp. | JFT |
| Apr 26, 1994 | K940482 | CIBA CORNING ACS FT3 IMMUNOASSAY Ciba Corning Diagnostics Corp. | CEC |
| Apr 21, 1994 | K934594 | MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM Ciba Corning Diagnostics Corp. | DGC |
| Apr 4, 1994 | K930534 | TMC I, II Ciba Corning Diagnostics Corp. | JJY |
| Mar 22, 1994 | K935219 | FERTILITY PLUS 1, 2, 3 Ciba Corning Diagnostics Corp. | JJY |
| Feb 3, 1994 | K935830 | CIBA CORNING 248 PH/BLOOD GAS ANALYZER Ciba Corning Diagnostics Corp. | CHL |
| Jan 3, 1994 | K934907 | 860 MEASURMENT SYSTEM Ciba Corning Diagnostics Corp. | CHL |
| Dec 10, 1993 | K934562 | CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY Ciba Corning Diagnostics Corp. | CDZ |
| Dec 3, 1993 | K932747 | CIBA CORNING ACS FREE T3 IMMUNOASSAY Ciba Corning Diagnostics Corp. | CDP |
| Dec 3, 1993 | K932715 | CIBA CORNING ACS ESTRADIOL IMMUNOASSAY Ciba Corning Diagnostics Corp. | CHP |
| Aug 19, 1993 | K933373 | CIBA CORNING 300 SERIES SYSTEM Ciba Corning Diagnostics Corp. | JGS |
| Aug 2, 1993 | K932955 | CIBA CORNING ACS PROGESTERONE IMMUNOASSAY Ciba Corning Diagnostics Corp. | JLS |
| Jun 7, 1993 | K931213 | ACS DIGOXIN IMMUNOASSAY Ciba Corning Diagnostics Corp. | KXT |
| Mar 19, 1993 | K925277 | CIBA CORNING ACS HCG IMMUNOASSAY Ciba Corning Diagnostics Corp. | JHI |
| Feb 23, 1993 | K923420 | CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY Ciba Corning Diagnostics Corp. | DHB |
| Dec 28, 1992 | K925257 | CIBA CORNING ACS T UPTAKE IMMUNOASSAY Ciba Corning Diagnostics Corp. | KHQ |
| Oct 13, 1992 | K923633 | MULTIQUAL ASSAY PRODUCTS Ciba Corning Diagnostics Corp. | JJY |
| Oct 13, 1992 | K923632 | MULTIQUAL UNASSAYED PRODUCTS Ciba Corning Diagnostics Corp. | JJY |
| Aug 20, 1992 | K914959 | MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM Ciba Corning Diagnostics Corp. | DHB |
| Jul 30, 1992 | K921403 | MODEL 654 ANALYZER Ciba Corning Diagnostics Corp. | JIH |
| Jun 9, 1992 | K921678 | CIBA CORNING ACS FOLATE IMMUNOASSAY Ciba Corning Diagnostics Corp. | JIX |
| Apr 8, 1992 | K920372 | ACS TOTAL IGE IMMUNOASSAY Ciba Corning Diagnostics Corp. | DGC |
| Mar 17, 1992 | K915366 | MODEL 560 EXPRESS CLINICAL CHEMISTRY ANALYZER Ciba Corning Diagnostics Corp. | JJE |
| Feb 18, 1992 | K915332 | MODEL 795 FLUOROMETER/DENSITOMETER Ciba Corning Diagnostics Corp. | JQT |
| Nov 22, 1991 | K914619 | CVM Ciba Corning Diagnostics Corp. | JJY |
| Oct 25, 1991 | K913646 | CIBA CORNING ACS T3 IMMUNOASSAY Ciba Corning Diagnostics Corp. | CDD |
| Oct 23, 1991 | K913332 | CIBA CORNING MODEL 270 CO-OXIMETER Ciba Corning Diagnostics Corp. | DQA |
| Aug 12, 1991 | K912583 | MAGIC LITE TSH (HS) IMMUNOASSAY Ciba Corning Diagnostics Corp. | JLW |
Newest 50 of 125.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||