The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Cd-chex Cd 34.
| Device ID | K993126 |
| 510k Number | K993126 |
| Device Name: | CD-CHEX CD 34 |
| Classification | Control, White-cell |
| Applicant | STRECK LABORATORIES, INC. 14124 INDUSTRIAL RD. Omaha, NE 68145 -0625 |
| Contact | Hal Sornson |
| Correspondent | Hal Sornson STRECK LABORATORIES, INC. 14124 INDUSTRIAL RD. Omaha, NE 68145 -0625 |
| Product Code | GGL |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-09-20 |
| Decision Date | 1999-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00844509000501 | K993126 | 000 |
| 00844509000495 | K993126 | 000 |
| 30844509000489 | K993126 | 000 |
| 30844509000472 | K993126 | 000 |
| 30844509000465 | K993126 | 000 |
| 20844509000482 | K993126 | 000 |
| 20844509000475 | K993126 | 000 |
| 20844509000468 | K993126 | 000 |