BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK— 510(k) K984546
Substantially EquivalentHemocleanse, Inc.
FDA 510(k) clearance K984546 for BIOLOGIC-DT MACHINE, MODEL DT-1000 AND BIOLOGIC-DT TREATMENT KIT, MODEL DT-1000-TK, Substantially Equivalent on 1999-08-13. Applicant: Hemocleanse, Inc.. Device class: 2.
Clearance details
- Applicant
- Hemocleanse, Inc.
- Product code
- Code FLD
- Device class
- Class 2
- Regulation
- 21 CFR 876.5870
- Advisory panel
- Gastroenterology, Urology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- West Lafayette, IN, US
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More clearances from Hemocleanse, Inc.
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