Sickle Cell Solubility Test Kit
FDA 510(k) K895745 · Simmler, Inc.
510(k) numberK895745
Submission
- Device name
- Sickle Cell Solubility Test Kit
- Applicant
- Simmler, Inc.
St. Louis, MO, US - Received
- September 26, 1989
- Decision date
- November 29, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K932872 | Sickle Cell Test KitJBB · Traditional | Histo-Med, Inc. | 08/16/1993SE |
More from Histo-Med, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K874903 | Multichem(R) Y -Glutamyltransferase (Y -Gt)JPZ · Traditional | 02/11/1988SE |
| K874595 | Multichem (R) Magnesium ReagentJGJ · Traditional | 01/21/1988SE |
| K874820 | Multichem HDL Precipitating Reagent #S0914LBR · Traditional | 01/07/1988SE |
| K874812 | Multichem Chloride Reagent S0933CHJ · Traditional | 12/18/1987SE |
| K874311 | Multichem (R) Total BilirubinCIG · Traditional | 11/25/1987SE |
| K874049 | Multichem Albumin Reagent S0902CIX · Traditional | 10/29/1987SE |
| K874038 | Multichem Inorganic Phosphorous S0923CEO · Traditional | 10/28/1987SE |
| K873725 | Multichem Creatinine Reagent S0917CGX · Traditional | 10/20/1987SE |
| K873761 | Multichem Alkaline Phosphatase (S0903)CJE · Traditional | 10/07/1987SE |
| K873697 | Multichem Calcium S0910CIC · Traditional | 10/02/1987SE |
Questions and answers
When was Sickle Cell Solubility Test Kit cleared by the FDA?
Sickle Cell Solubility Test Kit (K895745) received a 510(k) decision of Substantially Equivalent on November 29, 1989, 64 days after the submission was received.
What is the product code of K895745?
The FDA product code is JBB – Solubility, Hemoglobin, Abnormal, a Class II (moderate risk) device regulated under 21 CFR 864.7825.