510(k) K844159
- Device
- API UNISCEPT MIC 100UL
- Applicant
- ANALYTICAL PRODUCTS, INC.
- 510(k) number
- K844159
- Product code
- LTW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1984-12-14
- Date received
- 1984-10-24
- Regulation
- 866.1640
- Classification name
- Susceptibility Test Cards, Antimicrobial
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- SUSAN D TIEDY
- Address
- 200 Express St. Plainview NY US 11803 11803
FDA Registration Numbers#
- 2919016
- 8021914
- 3031977134
- 3003750284
- 3009171251
- 1119779
- 3013718871
- 1950204
- 3025775667
- 3009637528
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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