510(k) K932872
- Device
- SICKLE CELL TEST KIT
- Applicant
- HISTO-MED, INC.
- 510(k) number
- K932872
- Product code
- JBB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1993-08-16
- Date received
- 1993-06-14
- Regulation
- 864.7825
- Classification name
- Solubility, Hemoglobin, Abnormal
- Medical specialty
- Hematology
- Review panel
- Hematology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- WALTER LAMBERT
- Address
- 1104 Shadick Dr. Orange City FL US 32763 32763
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JBB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K895745 | SICKLE CELL SOLUBILITY TEST KIT | Simmler, Inc. | 1989-11-29 |
Legacy Summary#
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FDA Review#
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