The following data is part of a premarket notification filed by Streck Laboratories, Inc. with the FDA for Cal-chex, A Hematology Calibrator.
| Device ID | K840261 |
| 510k Number | K840261 |
| Device Name: | CAL-CHEX, A HEMATOLOGY CALIBRATOR |
| Classification | Calibrator For Hemoglobin And Hematocrit Measurement |
| Applicant | STRECK LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KRZ |
| CFR Regulation Number | 864.8165 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-01-05 |
| Decision Date | 1984-02-21 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00380740020347 | K840261 | 000 |
| 00630414224343 | K840261 | 000 |
| 30844509000243 | K840261 | 000 |
| 20844509000246 | K840261 | 000 |