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 |