The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Xe Check.
| Device ID | K994388 |
| 510k Number | K994388 |
| Device Name: | XE CHECK |
| 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 | 1999-12-28 |
| Decision Date | 2000-01-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14987562460578 | K994388 | 000 |
| 14987562460561 | K994388 | 000 |
| 14987562460288 | K994388 | 000 |