510(k) K820996
- Device
- SALMONELLA & SHIGELLA GROUPING SERA
- Applicant
- FISHER SCIENTIFIC CO., LLC.
- 510(k) number
- K820996
- Product code
- GRL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-05-03
- Date received
- 1982-04-09
- Regulation
- 866.3550
- Classification name
- Antigens, All Groups, Salmonella Spp.
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 1025402
- 3014150341
- 1649661
- 3005360469
- 3024463179
- 2032682
- 9611882
- 1119779
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code GRL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K945839 | SAS(TM) QC ANTIGENS FOR SALMONELLA ANTISERA | Sa Scientific, Inc. | 1995-03-07 |
Legacy Summary#
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FDA Review#
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