The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Para 5x.
| Device ID | K011410 |
| 510k Number | K011410 |
| Device Name: | PARA 5X |
| Classification | Mixture, Hematology Quality Control |
| Applicant | STRECK LABORATORIES, INC. 7002 SOUTH 109TH ST. La Vista, NE 68128 |
| Contact | Paul Kettelson |
| Correspondent | Paul Kettelson STRECK LABORATORIES, INC. 7002 SOUTH 109TH ST. La Vista, NE 68128 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-05-08 |
| Decision Date | 2001-06-26 |