510(k) K840257
- Device
- RAPID IMMUNO-ASSAY SYS
- Applicant
- APPLIED POLYTECHNOLOGY, INC.
- 510(k) number
- K840257
- Product code
- LLG
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-04-19
- Date received
- 1984-01-23
- Regulation
- 864.5425
- Classification name
- Kit, Igg, Platelet Associated
- Medical specialty
- Hematology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LLG #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K841465 | GENERAL DIAGNOSTICS PLATELET ANTIBODY | General Diagnostics | 1984-07-02 |
Legacy Summary#
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FDA Review#
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