The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Retic Chex Linearity.
| Device ID | K000115 |
| 510k Number | K000115 |
| Device Name: | RETIC CHEX LINEARITY |
| Classification | Mixture, Hematology Quality Control |
| Applicant | STRECK LABORATORIES, INC. 14124 INDUSTRIAL RD. Omaha, NE 68145 -0625 |
| Contact | Paul Kittelson |
| Correspondent | Paul Kittelson STRECK LABORATORIES, INC. 14124 INDUSTRIAL RD. Omaha, NE 68145 -0625 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-14 |
| Decision Date | 2000-03-27 |