The following data is part of a premarket notification filed by Histo-med, Inc. with the FDA for Sickle Cell Test Kit.
| Device ID | K932872 |
| 510k Number | K932872 |
| Device Name: | SICKLE CELL TEST KIT |
| Classification | Solubility, Hemoglobin, Abnormal |
| Applicant | HISTO-MED, INC. 1104 SHADICK DR. Orange City, FL 32763 |
| Contact | Walter Lambert |
| Correspondent | Walter Lambert HISTO-MED, INC. 1104 SHADICK DR. Orange City, FL 32763 |
| Product Code | JBB |
| CFR Regulation Number | 864.7825 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-06-14 |
| Decision Date | 1993-08-16 |