510(k) K813523
- Device
- ELECTRIC SELF STERILIZATION INOCUL. LOOP
- Applicant
- TECHHNILAB INSTRUMENTS, INC.
- 510(k) number
- K813523
- Product code
- LTB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-12-31
- Date received
- 1981-12-16
- Regulation
- 862.1235
- Classification name
- Cyclosporine Radioimmunoassay
- Medical specialty
- Clinical Chemistry
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 4221 Richmond Rd., NW Walker MI US 49534 49534
FDA Registration Numbers#
- 3018094310
- 1045254
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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