The following data is part of a premarket notification filed by Hf Scientific, Inc. with the FDA for Hemoglobin Determination Test Kit Hgb S-100 & 12.
| Device ID | K874429 |
| 510k Number | K874429 |
| Device Name: | HEMOGLOBIN DETERMINATION TEST KIT HGB S-100 & 12 |
| Classification | Hemoglobin S |
| Applicant | HF SCIENTIFIC, INC. 3052 METRO PARKWAY SE Ft. Myers, FL 33916 |
| Contact | Barbara H Sneade |
| Correspondent | Barbara H Sneade HF SCIENTIFIC, INC. 3052 METRO PARKWAY SE Ft. Myers, FL 33916 |
| Product Code | GIQ |
| CFR Regulation Number | 864.7415 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-10-28 |
| Decision Date | 1988-02-04 |