Alko Diagnostic Corp.
Holliston, MA, US
Alko Diagnostic Corp. appears in FDA device records in Holliston, MA. FDA records list 31 510(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
- 31
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 31 510(k) clearances for Alko Diagnostic Corp. between 1982 and 2000. The busiest year on record is 1994, with 12. The most recent is 2000, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1982 | 1 |
| 1989 | 2 |
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 12 |
| 1995 | 5 |
| 1996 | 3 |
| 1997 | 2 |
| 1998 | 1 |
| 2000 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K001484 | CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838 | JIX | Substantially Equivalent | |
| K982501 | ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 | JIX | Substantially Equivalent | |
| K972004 | ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS | CGZ | Substantially Equivalent | |
| K970921 | STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0) | JIX | Substantially Equivalent | |
| K962864 | THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS | KRZ | Substantially Equivalent | |
| K963734 | ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS | CGZ | Substantially Equivalent | |
| K960085 | ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS | JIX | Substantially Equivalent | |
| K955154 | CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT | JIX | Substantially Equivalent | |
| K951071 | ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS | KRZ | Substantially Equivalent | |
| K950902 | ALKO TONOMETERED SALINE CONTROL | JJS | Substantially Equivalent | |
| K945966 | ALKO CALIBRATORS AND FLUSH SOLUTION FOR IL 1300 SERIES PH/BLOOD GAS ANALYZERS | JIX | Substantially Equivalent | |
| K944922 | ALKO CAL PACKS FOR CORNING 654 ANALYZERS | JIX | Substantially Equivalent | |
| K944516 | FLUIDS PACK | JIT | Substantially Equivalent | |
| K940760 | FLUIDS PACK FOR CORING 238 | JIX | Substantially Equivalent | |
| K942549 | ALKO FLUIDS PACKS FOR NOVA 8 ANALYZERS | JIX | Substantially Equivalent | |
| K934607 | ALKO REAGENTS FOR BAXTER PARAMAX CHEMISTRY SYSTEM | JIX | Substantially Equivalent | |
| K933383 | REAGENTS FOR HITACHI ISE | JIX | Substantially Equivalent | |
| K935547 | CAL 1 AND CAL 2 STANDARDS/STANDARDS FOR IL 501 SODIUM/POTASSIUM ANALYZER | JIX | Substantially Equivalent | |
| K935018 | REAGENTS FOR ORION 1020, AND RELATED ANALYZERS | JIX | Substantially Equivalent | |
| K930796 | ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS | JZX | Substantially Equivalent | |
| K930231 | ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS | JIX | Substantially Equivalent | |
| K930199 | ALKO FLUIDS PACKS FOR NOVA ANALYZERS | JIX | Substantially Equivalent | |
| K925464 | CALIBRATION SOLUTIONS FOR USE ON ELECTROLYTE INSTR | JIX | Substantially Equivalent | |
| K925385 | REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA) | JIX | Substantially Equivalent | |
| K934701 | REAGENTS FOR COBAS ISE MODULE | JIX | Substantially Equivalent | |
| K926518 | ISE CALIBRATOR FOR DUPONT DIMENSION | JIX | Substantially Equivalent | |
| K915675 | ELECTRODE, ION SPECIFIC | JFP | Substantially Equivalent | |
| K915797 | CALIBRATOR | JIX | Substantially Equivalent | |
| K884266 | PH BLOOD GAS CONTROL PRODUCTS | JPK | Substantially Equivalent | |
| K884267 | ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS | CHL | Substantially Equivalent | |
| K813127 | SODIUM & POTASSIUM PRODUCTS | JIX | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- KRZCalibrator For Hemoglobin And Hematocrit Measurement
- JIXCalibrator, Multi-Analyte Mixture
- JITCalibrator, Secondary
- JJSControls For Blood-Gases, (Assayed And Unassayed)
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- JFPElectrode, Ion Specific, Calcium
- CGZElectrode, Ion-Specific, Chloride
- JZXEquipment, Rocket Immunoelectrophoresis
- JPKMixture, Hematology Quality Control
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain