BIO-CARB D16000, D16001, AND D17000
FDA 510(k) clearance K861646 · decided 1986-08-07
Clearance details
- K-number
- K861646
- Device name
- BIO-CARB D16000, D16001, AND D17000
- Applicant
- Societe D' Analyses Bio-Pharmaceutiques,Inc.
- Decision
- Substantially Equivalent
- Date received
- 1986-04-30
- Decision date
- 1986-08-07
- Days to decision
- 99 days
- Clearance type
- Traditional
- Product code
- FJH
- Device class
- 2
- Regulation number
- 876.5830
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Fort Worth, TX, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DEXTROLYTE II PERITONEAL DIALYSIS 48-3029-7 CLAMP (K920697) | National Medical Care, Medical Products Div., Inc. | 1992-09-21 |
| IDECAP DIALYZER (K852764) | Trans-National Trade Development Corp. | 1985-09-20 |
| CF 1211 CAPILLARY FLOW DIALYZER CODE (K822395) | Travenol Laboratories, S.A. | 1982-08-12 |
Recalls involving this device
No recalls on record reference this clearance.