The following data is part of a premarket notification filed by Stanbio Laboratory with the FDA for Stanbio Alpha-amylase Test Set, Catalog 0180-715.
| Device ID | K870746 |
| 510k Number | K870746 |
| Device Name: | STANBIO ALPHA-AMYLASE TEST SET, CATALOG 0180-715 |
| Classification | Catalytic Methods, Amylase |
| Applicant | STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Contact | W. R Pippin |
| Correspondent | W. R Pippin STANBIO LABORATORY 2930 EAST HOUSTON ST. San Antonio, TX 78202 |
| Product Code | JFJ |
| CFR Regulation Number | 862.1070 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-02-25 |
| Decision Date | 1987-06-01 |