Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ciba Corning Diagnostics Corp. — Predicate Candidate Screening
125 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
70 daysmedian FDA review time
157 days90th percentile
125clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K962559 | ACS CORTISOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1996-11-05 | 127 | 2 |
| K963251 | CIBA CORNING ACS;180 DPD ASSAY | Ciba Corning Diagnostics Corp. | 1996-10-15 | 57 | 0 |
| K961807 | CERTAIN HCT LEVEL A & LEVEL B/CVM HCT LEVELS 1,2,3, & 4 | Ciba Corning Diagnostics Corp. | 1996-07-26 | 77 | 0 |
| K961657 | CIBA CORNING 400 SYSTEM | Ciba Corning Diagnostics Corp. | 1996-06-25 | 56 | 0 |
| K962021 | CIBA CORNING 348 SYSTEM | Ciba Corning Diagnostics Corp. | 1996-06-24 | 32 | 0 |
| K962126 | ACS CKMB II IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1996-06-21 | 18 | 0 |
| K962041 | ACS LH2 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1996-06-21 | 24 | 0 |
| K961510 | ACS FRT4 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1996-06-17 | 59 | 1 |
| K960246 | LIQUID CARDIAC MARKER 1,2,3 ASSAYED | Ciba Corning Diagnostics Corp. | 1996-04-23 | 98 | 0 |
| K955873 | ACS PHENYTOIN ASSAY | Ciba Corning Diagnostics Corp. | 1996-03-11 | 76 | 0 |
| K954697 | CIBA CORNING ACS ESTRADIOL-6 ASSAY | Ciba Corning Diagnostics Corp. | 1995-12-13 | 62 | 0 |
| K953021 | ACS PHENOBARBITAL | Ciba Corning Diagnostics Corp. | 1995-12-11 | 165 | 0 |
| K953020 | ACS GENTAMICIN | Ciba Corning Diagnostics Corp. | 1995-08-02 | 34 | 0 |
| K951169 | CIBA CORINING ACS THEOPHYLLINE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1995-06-20 | 97 | 0 |
| K951059 | CIBA CORNING ACS VANCOMYCIN IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1995-06-19 | 104 | 0 |
| K951796 | CIBA CORNING ACS THYROID STIMULATING HORMONE (TSH-3) IMMUNOA | Ciba Corning Diagnostics Corp. | 1995-06-13 | 55 | 0 |
| K945367 | CIBA CORNING ACS CORTISOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1995-05-05 | 221 | 0 |
| K946206 | CIBA CORNING 8-- SERIES CO-OXIMETER | Ciba Corning Diagnostics Corp. | 1995-01-30 | 40 | 0 |
| K946224 | CERTAIN(R) ELITE LEVEL 1, 2 AND 3 | Ciba Corning Diagnostics Corp. | 1995-01-30 | 77 | 0 |
| K943297 | CIBA CORNING ACS FOLATE ASSAY | Ciba Corning Diagnostics Corp. | 1994-12-12 | 157 | 0 |
| K935228 | MODEL 644 SWEAT DILUENT | Ciba Corning Diagnostics Corp. | 1994-08-01 | 273 | 0 |
| K940810 | CIBA CORNING ACS:180 AUTO CHEMILUMIN SYST, MODIF | Ciba Corning Diagnostics Corp. | 1994-05-23 | 90 | 0 |
| K934317 | CIDBA CORNING ACS CORTISOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1994-05-13 | 254 | 0 |
| K940482 | CIBA CORNING ACS FT3 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1994-04-26 | 83 | 0 |
| K934594 | MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM | Ciba Corning Diagnostics Corp. | 1994-04-21 | 209 | 0 |
| K930534 | TMC I, II | Ciba Corning Diagnostics Corp. | 1994-04-04 | 426 | 0 |
| K935219 | FERTILITY PLUS 1, 2, 3 | Ciba Corning Diagnostics Corp. | 1994-03-22 | 147 | 0 |
| K935830 | CIBA CORNING 248 PH/BLOOD GAS ANALYZER | Ciba Corning Diagnostics Corp. | 1994-02-03 | 58 | 0 |
| K934907 | 860 MEASURMENT SYSTEM | Ciba Corning Diagnostics Corp. | 1994-01-03 | 80 | 0 |
| K934562 | CIBA CORNING ACS TESTOSTERONE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1993-12-10 | 85 | 0 |
| K932747 | CIBA CORNING ACS FREE T3 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1993-12-03 | 178 | 0 |
| K932715 | CIBA CORNING ACS ESTRADIOL IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1993-12-03 | 182 | 0 |
| K933373 | CIBA CORNING 300 SERIES SYSTEM | Ciba Corning Diagnostics Corp. | 1993-08-19 | 38 | 0 |
| K932955 | CIBA CORNING ACS PROGESTERONE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1993-08-02 | 46 | 7 |
| K931213 | ACS DIGOXIN IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1993-06-07 | 89 | 0 |
| K925277 | CIBA CORNING ACS HCG IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1993-03-19 | 150 | 0 |
| K923420 | CIBA CORNING MAGIC LITE SQ SPECIFIC IGE ASSAY | Ciba Corning Diagnostics Corp. | 1993-02-23 | 225 | 0 |
| K925257 | CIBA CORNING ACS T UPTAKE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1992-12-28 | 70 | 0 |
| K923632 | MULTIQUAL UNASSAYED PRODUCTS | Ciba Corning Diagnostics Corp. | 1992-10-13 | 84 | 0 |
| K923633 | MULTIQUAL ASSAY PRODUCTS | Ciba Corning Diagnostics Corp. | 1992-10-13 | 84 | 0 |
| K914959 | MAGIC LITE SQ SPECIFIC IGE IMMUNOASSAY SYSTEM | Ciba Corning Diagnostics Corp. | 1992-08-20 | 289 | 0 |
| K921403 | MODEL 654 ANALYZER | Ciba Corning Diagnostics Corp. | 1992-07-30 | 128 | 0 |
| K921678 | CIBA CORNING ACS FOLATE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1992-06-09 | 62 | 0 |
| K920372 | ACS TOTAL IGE IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1992-04-08 | 71 | 0 |
| K915366 | MODEL 560 EXPRESS CLINICAL CHEMISTRY ANALYZER | Ciba Corning Diagnostics Corp. | 1992-03-17 | 111 | 0 |
| K915332 | MODEL 795 FLUOROMETER/DENSITOMETER | Ciba Corning Diagnostics Corp. | 1992-02-18 | 84 | 0 |
| K914619 | CVM | Ciba Corning Diagnostics Corp. | 1991-11-22 | 37 | 0 |
| K913646 | CIBA CORNING ACS T3 IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1991-10-25 | 70 | 0 |
| K913332 | CIBA CORNING MODEL 270 CO-OXIMETER | Ciba Corning Diagnostics Corp. | 1991-10-23 | 90 | 0 |
| K912583 | MAGIC LITE TSH (HS) IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1991-08-12 | 61 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda