The following data is part of a premarket notification filed by Marilyn L. Amick with the FDA for Abnormal Hemoglobin Control.
| Device ID | K802569 |
| 510k Number | K802569 |
| Device Name: | ABNORMAL HEMOGLOBIN CONTROL |
| Classification | Whole Blood Hemoglobin Determination |
| Applicant | MARILYN L. AMICK 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KHG |
| CFR Regulation Number | 864.7500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-10-17 |
| Decision Date | 1980-11-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817869020236 | K802569 | 000 |
| 00817869020069 | K802569 | 000 |
| 00817869020076 | K802569 | 000 |
| 00817869020083 | K802569 | 000 |
| 00817869020090 | K802569 | 000 |
| 00817869020106 | K802569 | 000 |
| 00817869020113 | K802569 | 000 |
| 00817869020120 | K802569 | 000 |
| 00817869020137 | K802569 | 000 |
| 00817869020144 | K802569 | 000 |
| 00817869020151 | K802569 | 000 |
| 00817869020182 | K802569 | 000 |
| 00817869020199 | K802569 | 000 |
| 00817869020205 | K802569 | 000 |
| 00817869020212 | K802569 | 000 |
| 00817869020229 | K802569 | 000 |
| 00817869020052 | K802569 | 000 |