Diagnostics makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 14, 2026, FDA's public records list Alko Diagnostic with 31 510(k) clearances. The most recent is a 510(k) clearance dated Jun 19, 2000: CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SO….
| Jun 19, 2000 | CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION 2, MODEL A943-839; RINSE SOLUTION KIT, MODEL A943-838K001484 · JIX | 510(k) clearances |
| Sep 1, 1998 | ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A443-315, CO2 ACID REAGENT A443-330, CO2 ALKALINE BUFFER A44K982501 · JIX | 510(k) clearances |
| Jun 16, 1997 | ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMSK972004 · CGZ | 510(k) clearances |
| Apr 8, 1997 | STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0)K970921 · JIX | 510(k) clearances |
| Dec 18, 1996 | THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERSK962864 · KRZ | 510(k) clearances |
| Oct 24, 1996 | ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMISTRY SYSTEMSK963734 · CGZ | 510(k) clearances |
| Mar 11, 1996 | ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK SYSTEMSK960085 · JIX | 510(k) clearances |
| Dec 11, 1995 | CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KITK955154 · JIX | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
