Sickle Cell Test Kit
FDA 510(k) K932872 · Histo-Med, Inc.
510(k) numberK932872
Submission
- Device name
- Sickle Cell Test Kit
- Applicant
- Histo-Med, Inc.
Orange City, FL, US - Received
- June 14, 1993
- Decision date
- August 16, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JBB – Solubility, Hemoglobin, Abnormal
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7825
- Specialty
- Hematology
Other 510(k)s with product code JBB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K895745 | Sickle Cell Solubility Test KitJBB · Traditional | Simmler, Inc. | 11/29/1989SE |
Questions and answers
When was Sickle Cell Test Kit cleared by the FDA?
Sickle Cell Test Kit (K932872) received a 510(k) decision of Substantially Equivalent on August 16, 1993, 63 days after the submission was received.
What is the product code of K932872?
The FDA product code is JBB – Solubility, Hemoglobin, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.7825.