The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Stak-chex Plus Retics.
| Device ID | K992887 |
| 510k Number | K992887 |
| Device Name: | STAK-CHEX PLUS RETICS |
| Classification | Mixture, Control, White-cell And Red-cell Indices |
| 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 | GLQ |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-27 |
| Decision Date | 1999-11-22 |
| Summary: | summary |