The following data is part of a premarket notification filed by American Biomedical Products, Inc. with the FDA for B. Fragtex.
| Device ID | K881380 |
| 510k Number | K881380 |
| Device Name: | B. FRAGTEX |
| Classification | Kit, Anaerobic Identification |
| Applicant | AMERICAN BIOMEDICAL PRODUCTS, INC. P.O. BOX 690355 Tulsa, OK 74169 |
| Contact | James F Maher |
| Correspondent | James F Maher AMERICAN BIOMEDICAL PRODUCTS, INC. P.O. BOX 690355 Tulsa, OK 74169 |
| Product Code | JSP |
| CFR Regulation Number | 866.2660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-01 |
| Decision Date | 1988-10-06 |