510(k) K893519
- Device
- TWIN-FUSOR/UNI-FUSOR BLOOD & FLUID INFUSION CUFF
- Applicant
- STATLABS, INC.
- 510(k) number
- K893519
- Product code
- KZB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-08-15
- Date received
- 1989-05-08
- Regulation
- 866.2170
- Classification name
- Automated Colony Counter
- Medical specialty
- Microbiology
- Review panel
- Microbiology
- Device class
- 1
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANDY WOODS
- Address
- 169 London Ln. Franklin TN US 37064 37064
FDA Registration Numbers#
- 1119779
- 3009288740
- 1319721
- 3043088937
- 3010141591
- 3043138885
- 3027645317
Source Documents#
510(k) summary PDF not indicated by FDA
Legacy Summary#
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FDA Review#
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