The following data is part of a premarket notification filed by Hdc Corp. with the FDA for Entero-test Hp, Model #102-01.
| Device ID | K983119 |
| 510k Number | K983119 |
| Device Name: | ENTERO-TEST HP, MODEL #102-01 |
| Classification | Device, Specimen Collection |
| Applicant | HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Contact | Len Ross |
| Correspondent | Len Ross HDC CORP. 2109 O'TOOLE AVE. San Jose, CA 95131 |
| Product Code | LIO |
| CFR Regulation Number | 866.2900 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-08 |
| Decision Date | 1999-03-15 |
| Summary: | summary |