510(k) K790986
- Device
- RF CONTROLS
- Applicant
- WAMPOLE LABORATORIES
- 510(k) number
- K790986
- Product code
- DMR
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-06-28
- Date received
- 1979-05-25
- Regulation
- 862.3240
- Classification name
- Solution, M-nitrophenol, Specific Reagent For Cholinesterase
- Medical specialty
- Toxicology
- Review panel
- Immunology
- Device class
- 1
- 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
Legacy Summary#
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FDA Review#
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