Company ยท US
Alko Diagnostic Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1982 to 2000. 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 |
|---|---|---|
| JIX | Calibrator, Multi-Analyte Mixture | 21 |
| CGZ | Electrode, Ion-Specific, Chloride | 2 |
| KRZ | Calibrator For Hemoglobin And Hematocrit Measurement | 2 |
| CHL | Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph | 1 |
| JFP | Electrode, Ion Specific, Calcium | 1 |
| JIT | Calibrator, Secondary | 1 |
| JJS | Controls For Blood-Gases, (Assayed And Unassayed) | 1 |
| JPK | Mixture, Hematology Quality Control | 1 |
| JZX | Equipment, Rocket Immunoelectrophoresis | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 19, 2000 | K001484 | CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838 Alko Diagnostic Corp. | JIX |
| Sep 1, 1998 | K982501 | ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44 Alko Diagnostic Corp. | JIX |
| Jun 16, 1997 | K972004 | ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS Alko Diagnostic Corp. | CGZ |
| Apr 8, 1997 | K970921 | STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0) Alko Diagnostic Corp. | JIX |
| Dec 18, 1996 | K962864 | THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS Alko Diagnostic Corp. | KRZ |
| Oct 24, 1996 | K963734 | ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMS Alko Diagnostic Corp. | CGZ |
| Mar 11, 1996 | K960085 | ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMS Alko Diagnostic Corp. | JIX |
| Dec 11, 1995 | K955154 | CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT Alko Diagnostic Corp. | JIX |
| Jul 24, 1995 | K951071 | ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZERS Alko Diagnostic Corp. | KRZ |
| Mar 30, 1995 | K950902 | ALKO TONOMETERED SALINE CONTROL Alko Diagnostic Corp. | JJS |
| Feb 10, 1995 | K945966 | ALKO CALIBRATORS AND FLUSH SOLUTION FOR IL 1300 SERIES PH/BLOOD GAS ANALYZERS Alko Diagnostic Corp. | JIX |
| Feb 10, 1995 | K944922 | ALKO CAL PACKS FOR CORNING 654 ANALYZERS Alko Diagnostic Corp. | JIX |
| Nov 2, 1994 | K944516 | FLUIDS PACK Alko Diagnostic Corp. | JIT |
| Sep 6, 1994 | K940760 | FLUIDS PACK FOR CORING 238 Alko Diagnostic Corp. | JIX |
| Jul 28, 1994 | K942549 | ALKO FLUIDS PACKS FOR NOVA 8 ANALYZERS Alko Diagnostic Corp. | JIX |
| Mar 28, 1994 | K934607 | ALKO REAGENTS FOR BAXTER PARAMAX CHEMISTRY SYSTEM Alko Diagnostic Corp. | JIX |
| Mar 9, 1994 | K933383 | REAGENTS FOR HITACHI ISE Alko Diagnostic Corp. | JIX |
| Jan 18, 1994 | K935547 | CAL 1 AND CAL 2 STANDARDS/STANDARDS FOR IL 501 SODIUM/POTASSIUM ANALYZER Alko Diagnostic Corp. | JIX |
| Jan 18, 1994 | K935018 | REAGENTS FOR ORION 1020, AND RELATED ANALYZERS Alko Diagnostic Corp. | JIX |
| Jan 13, 1994 | K930796 | ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS Alko Diagnostic Corp. | JZX |
| Jan 13, 1994 | K930231 | ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS Alko Diagnostic Corp. | JIX |
| Jan 13, 1994 | K930199 | ALKO FLUIDS PACKS FOR NOVA ANALYZERS Alko Diagnostic Corp. | JIX |
| Jan 13, 1994 | K925464 | CALIBRATION SOLUTIONS FOR USE ON ELECTROLYTE INSTR Alko Diagnostic Corp. | JIX |
| Jan 13, 1994 | K925385 | REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA) Alko Diagnostic Corp. | JIX |
| Dec 2, 1993 | K934701 | REAGENTS FOR COBAS ISE MODULE Alko Diagnostic Corp. | JIX |
| Jan 28, 1993 | K926518 | ISE CALIBRATOR FOR DUPONT DIMENSION Alko Diagnostic Corp. | JIX |
| Apr 29, 1992 | K915675 | ELECTRODE, ION SPECIFIC Alko Diagnostic Corp. | JFP |
| Jan 30, 1992 | K915797 | CALIBRATOR Alko Diagnostic Corp. | JIX |
| May 16, 1989 | K884266 | PH BLOOD GAS CONTROL PRODUCTS Alko Diagnostic Corp. | JPK |
| May 4, 1989 | K884267 | ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS Alko Diagnostic Corp. | CHL |
| Jan 22, 1982 | K813127 | SODIUM & POTASSIUM PRODUCTS Alko Diagnostic Corp. | JIX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||