Abbott Diagnostics
Mountain View, CA, US
Abbott Diagnostics appears in FDA device records in Mountain View, CA. FDA records list 28 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 28
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 28 510(k) clearances for Abbott Diagnostics between 1981 and 1997. The busiest year on record is 1983, with 5. The most recent is 1997, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1981 | 2 |
| 1982 | 2 |
| 1983 | 5 |
| 1984 | 3 |
| 1985 | 4 |
| 1986 | 1 |
| 1987 | 5 |
| 1988 | 2 |
| 1989 | 1 |
| 1996 | 1 |
| 1997 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K964185 | IMX CA 125 | LTK | Substantially Equivalent | |
| K972182 | ABBOTT STREP A CONTROLS | MJZ | Substantially Equivalent | |
| K961439 | ABBOTT CELL-DYN 4000 SYSTEM | GKZ | Substantially Equivalent | |
| K890491 | CELL-DYN 3000 MULTI-PARAMETER HEMATOLOGY ANALYER | GKZ | Substantially Equivalent | |
| K881242 | CELL-DYN RAPID-LYSE AND HEMOGLOBLIN | GJZ | Substantially Equivalent | |
| K881130 | CELL-DYN ISOTONIC DILUENT | GIF | Substantially Equivalent | |
| K873348 | CELL-DYN DIFF SCREEN, AUTO. & SEMI AUTO. LYTIC AG. | GGK | Substantially Equivalent | |
| K873347 | CELL-DYN DIFF. SCREEN ISOTONIC DILUENT | GIF | Substantially Equivalent | |
| K873408 | MODEL 690 SPECTROPHOTOMETER | JJQ | Substantially Equivalent | |
| K872761 | CELL-DYN 610 HEMATOLOGY ANALYZER | GKZ | Substantially Equivalent | |
| K870233 | CELL-DYN 1600 MULTIPARAMETER AUTO. HEMA. ANALYZER | GKZ | Substantially Equivalent | |
| K854368 | CELL-DYN 1500 MULTI-PARAMETER HEMATOLOGY ANALYZER | GKZ | Substantially Equivalent | |
| K852371 | CELL-DYN 2000 AUTOMATED MULTI-PARAMETER HEMATOLOGY | GKZ | Substantially Equivalent | |
| K852372 | CELL-DYN BRAND HEMATOLOGY REAGENTS | JPK | Substantially Equivalent | |
| K852373 | AD150, AUTOMATED HEMATOLOGY DILUTOR | GKH | Substantially Equivalent | |
| K845019 | CELL-DYN 1000 AUTOMATED HEMATOLOGY ANALYZER | GKL | Substantially Equivalent | |
| K842786 | DYNA-LYTE 2000 | CEM | Substantially Equivalent | |
| K842446 | DILU-MATIC 140 | GKH | Substantially Equivalent | |
| K840170 | CELL-DYN 100 WHOLE BLOOD PLATELET | GKL | Substantially Equivalent | |
| K832643 | CELL-DYN 900 HEMATOLOGY ANALYZER | GKL | Substantially Equivalent | |
| K832206 | SPECTROPHOTOMETER #390 | JJQ | Substantially Equivalent | |
| K832038 | CELL-DYN 300 HEMATOLOGY ANALYZER | GKL | Substantially Equivalent | |
| K831368 | CELL-DYN 400 HEMOTOLOGY ANALYZER | GKL | Substantially Equivalent | |
| K830624 | FLUOROMETER, GENERAL USE | KHO | Substantially Equivalent | |
| K823344 | HEMATOLOGY ANALYZER | GKL | Substantially Equivalent | |
| K822720 | MODEL 340 SPECTROPHOTOMETER | JJQ | Substantially Equivalent | |
| K803218 | CELL DYN 800 HEMATOLOGY ANALYZER | GKL | Substantially Equivalent | |
| K810135 | MODEL AM 721 ELECTROLYTE ANALYZER | JGS | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GKHApparatus, Automated Blood Cell Diluting
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- GKLCounter, Cell, Automated (Particle Counter)
- GKZCounter, Differential Cell
- GJZCyanomethemoglobin Reagent And Standard Solution
- GIFDiluent, Blood Cell
- CEMElectrode, Ion Specific, Potassium
- JGSElectrode, Ion Specific, Sodium
- KHOFluorometer, For Clinical Use
- MJZKit, Direct Antigen, Positive Control
- JPKMixture, Hematology Quality Control
- GGKProducts, Red-Cell Lysing Products
- LTKTest, Epithelial Ovarian Tumor-Associated Antigen (Ca125)
Recall records
No recall records for this company in the ingested FDA data.
Verification record
There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.
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Data as of , FDA export datePage updated Source: openFDA, public domain