510(k) K810871
- Device
- LIGHTNING DIALYZER
- Applicant
- CLINTOX LABORATORIES, INC.
- 510(k) number
- K810871
- Product code
- DHY
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1981-07-10
- Date received
- 1981-03-31
- Regulation
- 866.5065
- Classification name
- Ng4m(a), Antigen, Antiserum, Control
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Related Records
Applicant Contact
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents
510(k) summary PDF not indicated by FDA
Legacy Summary
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FDA Review
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