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 |