510(k) K842527
- Device
- AMIZYME-SCHISTOSOMA SPP. TEST KIT
- Applicant
- AMICO LAB, INC.
- 510(k) number
- K842527
- Product code
- GNH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-09-05
- Date received
- 1984-06-28
- Regulation
- 866.3600
- Classification name
- Antigen, Fluorescent Antibody Test, Schistosoma Mansoni
- 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#
- 3005542422
- 3007118747
- 3003718445
- 2133982
- 3026241718
- 3003268355
- 2031468
- 3011527950
- 3022178699
- 3008191245
- 2245285
- 2029372
- 3007361513
- 3002800697
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GNH #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K842660 | ANTI-SCHISTOSOMA SPECIES KIT | Amico Lab, Inc. | 1984-10-30 |
Legacy Summary#
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FDA Review#
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