The following data is part of a premarket notification filed by Biomed Diagnostics, Inc. with the FDA for Inpouch-tv Pouch.
| Device ID | K896296 |
| 510k Number | K896296 |
| Device Name: | INPOUCH-TV POUCH |
| Classification | Culture Media, Propagating Transport |
| Applicant | BIOMED DIAGNOSTICS, INC. 810 MENKAR AVE. San Jose, CA 95128 |
| Contact | Becker, Phd |
| Correspondent | Becker, Phd BIOMED DIAGNOSTICS, INC. 810 MENKAR AVE. San Jose, CA 95128 |
| Product Code | JSN |
| CFR Regulation Number | 866.2390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-10-31 |
| Decision Date | 1990-01-29 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B08810310 | K896296 | 000 |