The following data is part of a premarket notification filed by Biopool Intl., Inc. with the FDA for Fetal D Tection Kit.
| Device ID | K980314 |
| 510k Number | K980314 |
| Device Name: | FETAL D TECTION KIT |
| Classification | Test, Screening, For D Positive Fetal Rbc's |
| Applicant | BIOPOOL INTL., INC. 1230 WILSON DR. West Chester, PA 19380 |
| Contact | Peter L Minetti |
| Correspondent | Peter L Minetti BIOPOOL INTL., INC. 1230 WILSON DR. West Chester, PA 19380 |
| Product Code | LIM |
| CFR Regulation Number | 864.7455 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-01-27 |
| Decision Date | 1998-04-08 |