The following data is part of a premarket notification filed by Alko Diagnostic Corp. with the FDA for Standard A Multiply (a540-0), Standard B Multiply (a550-0), Standard C Multiply (a560-0).
| Device ID | K970921 |
| 510k Number | K970921 |
| Device Name: | STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0), STANDARD C MULTIPLY (A560-0) |
| Classification | Calibrator, Multi-analyte Mixture |
| Applicant | ALKO DIAGNOSTIC CORP. 333 FISKE ST. Holliston, MA 01746 |
| Contact | Janet A Mcgrath |
| Correspondent | Janet A Mcgrath ALKO DIAGNOSTIC CORP. 333 FISKE ST. Holliston, MA 01746 |
| Product Code | JIX |
| CFR Regulation Number | 862.1150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-03-12 |
| Decision Date | 1997-04-08 |
| Summary: | summary |