IDECAP DIALYZER
FDA 510(k) clearance K852764 · decided 1985-09-20
Clearance details
- K-number
- K852764
- Device name
- IDECAP DIALYZER
- Applicant
- Trans-National Trade Development Corp.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-28
- Decision date
- 1985-09-20
- Days to decision
- 84 days
- Clearance type
- Traditional
- Product code
- FJH
- Device class
- 2
- Regulation number
- 876.5830
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- New York, NY, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Trans-National Trade Development Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
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 |
| BIO-CARB D16000, D16001, AND D17000 (K861646) | Societe D' Analyses Bio-Pharmaceutiques,Inc. | 1986-08-07 |
| 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.