510(k) K885114
- Device
- SALMONELLA IFA*
- Applicant
- INVESTIGACION FARMACEUTICA S.A. DE C.V.
- 510(k) number
- K885114
- Product code
- GHC
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-08-15
- Date received
- 1988-12-12
- Regulation
- 864.6700
- Classification name
- Tube, Sedimentation Rate
- Medical specialty
- Hematology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SMITHERS HOGG
- Address
- Calle 13-E # 5 Civac Jiutepec, Morelos Mexico MX
FDA Registration Numbers#
- 3016884191
- 3010370650
- 2243072
- 3010352064
- 9613662
- 3010420046
- 3029895090
- 3018126397
- 3045058049
- 2244900
- 3010194621
- 3011215096
- 3013894805
- 9615056
- 3015505238
- 3019387954
- 9617475
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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