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 |