The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Pat Platelet Aggregation Test.
| Device ID | K881829 |
| 510k Number | K881829 |
| Device Name: | PAT PLATELET AGGREGATION TEST |
| Classification | Aggregrometer, Platelet |
| Applicant | STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
| Contact | Halvor Sornson |
| Correspondent | Halvor Sornson STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
| Product Code | JBX |
| CFR Regulation Number | 864.6675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-29 |
| Decision Date | 1988-07-01 |