The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Tnt Troponin T.
| Device ID | K942632 |
| 510k Number | K942632 |
| Device Name: | TNT TROPONIN T |
| Classification | Single (specified) Analyte Controls (assayed And Unassayed) |
| Applicant | STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
| Contact | Theodore Heise |
| Correspondent | Theodore Heise STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
| Product Code | JJX |
| CFR Regulation Number | 862.1660 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-03 |
| Decision Date | 1994-09-09 |