The following data is part of a premarket notification filed by Sandare Chemical Co., Inc. with the FDA for Sandare Lyophilized Hemoglobin Controls.
| Device ID | K800780 |
| 510k Number | K800780 |
| Device Name: | SANDARE LYOPHILIZED HEMOGLOBIN CONTROLS |
| Classification | Mixture, Hematology Quality Control |
| Applicant | SANDARE CHEMICAL CO., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JPK |
| CFR Regulation Number | 864.8625 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-04-08 |
| Decision Date | 1980-04-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727011497 | K800780 | 000 |