The following data is part of a premarket notification filed by Pointe Scientific, Inc. with the FDA for Hemoglobin.
| Device ID | K851432 |
| 510k Number | K851432 |
| Device Name: | HEMOGLOBIN |
| Classification | Whole Blood Hemoglobin Determination |
| Applicant | POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit, MI 48224 |
| Contact | Janusz M Szyszko |
| Correspondent | Janusz M Szyszko POINTE SCIENTIFIC, INC. P.O. BOX 8569 Detroit, MI 48224 |
| Product Code | KHG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-04-10 |
| Decision Date | 1985-07-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811727014528 | K851432 | 000 |
| 00811727011480 | K851432 | 000 |
| 00811727011473 | K851432 | 000 |
| 00811727011466 | K851432 | 000 |