510(k) K791451
- Device
- AGGLUTINOTEST-ECHINOCOCCOSIS
- Applicant
- VOLU SOL MEDICAL INDUSTRIES
- 510(k) number
- K791451
- Product code
- GPF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1979-09-24
- Date received
- 1979-08-06
- Regulation
- 866.3200
- Classification name
- Antigen, Agglutinating, Echinococcus Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3007208259
- 3005542422
- 2133982
- 3003718445
- 3026241718
- 1222302
- 3011527950
- 3008191245
- 2245285
- 9615056
- 2029372
- 3002800697
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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