The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Scs-1000 (sysmex Calibrator System).
| Device ID | K943268 |
| 510k Number | K943268 |
| Device Name: | SCS-1000 (SYSMEX CALIBRATOR SYSTEM) |
| Classification | Calibrator For Red-cell And White-cell Counting |
| Applicant | STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
| Contact | Theodore W Heise |
| Correspondent | Theodore W Heise STRECK LABORATORIES, INC. 14306 INDUSTRIAL RD. P.O. BOX 37625 Omaha, NE 68144 |
| Product Code | KSA |
| CFR Regulation Number | 864.8185 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-07 |
| Decision Date | 1994-12-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14987562460370 | K943268 | 000 |