510(k) K895745
- Device
- SICKLE CELL SOLUBILITY TEST KIT
- Applicant
- SIMMLER, INC.
- 510(k) number
- K895745
- Product code
- JBB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-11-29
- Date received
- 1989-09-26
- Regulation
- 864.7825
- Classification name
- Solubility, Hemoglobin, Abnormal
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- CARL R BURKS
- Address
- Post Office Box 25179 St. Louis MO US 63125 63125
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JBB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K932872 | SICKLE CELL TEST KIT | Histo-Med, Inc. | 1993-08-16 |
Legacy Summary#
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FDA Review#
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