The following data is part of a premarket notification filed by Tech-co, Inc. with the FDA for Hemoglobin.
| Device ID | K883683 |
| 510k Number | K883683 |
| Device Name: | HEMOGLOBIN |
| Classification | Cyanomethemoglobin Reagent And Standard Solution |
| Applicant | TECH-CO, INC. 24111 BEVERLY Oak Park, MI 48237 |
| Contact | Chen, Ph.d. |
| Correspondent | Chen, Ph.d. TECH-CO, INC. 24111 BEVERLY Oak Park, MI 48237 |
| Product Code | GJZ |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-08-29 |
| Decision Date | 1988-10-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10673486001921 | K883683 | 000 |
| 10673486001914 | K883683 | 000 |