The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Amylase Eps-g7 (liquid) Reagent Set, (hitachi Analyzers).
| Device ID | K023396 |
| 510k Number | K023396 |
| Device Name: | AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS) |
| Classification | Saccharogenic, Amylase |
| Applicant | POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Contact | Ron Jamison |
| Correspondent | Ron Jamison POINTE SCIENTIFIC, INC. 1025 JOHN A. PAPALAS DR. Lincoln Park, MI 48146 |
| Product Code | CIJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-09 |
| Decision Date | 2002-12-23 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014931 | K023396 | 000 |
| 00811727014641 | K023396 | 000 |
| 00811727012906 | K023396 | 000 |
| 00811727016034 | K023396 | 000 |