The following data is part of a premarket notification filed by B & D Corp. with the FDA for B&d Activated Clotting Time (act) Test Tubes Bd-c101 (diatomaceous Earth) And Bd-k101 (kaolin).
| Device ID | K971935 |
| 510k Number | K971935 |
| Device Name: | B&D ACTIVATED CLOTTING TIME (ACT) TEST TUBES BD-C101 (DIATOMACEOUS EARTH) AND BD-K101 (KAOLIN) |
| Classification | Activated Whole Blood Clotting Time |
| Applicant | B & D CORP. 14 MICHAEL DR. Metuchen, NJ 08840 |
| Contact | Ladislau Biro |
| Correspondent | Ladislau Biro B & D CORP. 14 MICHAEL DR. Metuchen, NJ 08840 |
| Product Code | JBP |
| CFR Regulation Number | 864.7140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-05-27 |
| Decision Date | 1997-10-01 |
| Summary: | summary |