AMUKIN D
FDA 510(k) clearance K992016 · decided 2000-01-10
Clearance details
- K-number
- K992016
- Device name
- AMUKIN D
- Applicant
- Amuchina Intl., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-06-15
- Decision date
- 2000-01-10
- Days to decision
- 209 days
- Clearance type
- Traditional
- Product code
- LIF
- Device class
- 2
- Regulation number
- 876.5820
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Gaithersburg, MD, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
| CLEARFLUX DIALYZER REPROCESSING SYSTEM (K091360) | Novaflux Technologies | 2010-11-03 |
| ASSIST HEADER CLEANER (K043126) | Alcavis International, Inc. | 2005-02-03 |
| STERICHEK GLUTARALDEHYDE REAGENT STRIPS (K040660) | Hach Company | 2004-11-15 |
| RENACLEAN SH DIALYZER CLEANING SYSTEM (K033505) | Minntech Corp. | 2004-04-27 |
| MAKY 21.1 DIALYZER REPROCESSING SYSTEM (K024076) | Hdc Maquinolas, LLC | 2003-09-26 |
| ARM AUTOMATIC REPROCESSING MACHINE (K013713) | Alcavis International Incorporated | 2002-07-15 |
| RENACLEAR DIALYZER CLEANING SYSTEM (K991851) | Minntech Corp. | 1999-08-30 |
| POTENCY TEST STRIPS, INDICATOR TEST STRIPS (K974426) | Reprocessing Products Corp | 1999-02-10 |
| STERICHEK(TM) RESIDUAL PEROXIDE REAGENT STRPS (K974798) | Environmental Test Systems, Inc. | 1998-03-20 |
| ALEXANDER MANUFACTURING RECHARGEABLE BATTERY (M1/T) (K970799) | Alexander Mfg. Co. | 1997-05-14 |
| DPS 4 DIALYZER PREPARATION SYSTEM (K955299) | Seratronics, Inc. | 1996-10-21 |
| DRS 4 DIALYZER REPROCESSING SYSTEM (K931336) | Seratronics, Inc. | 1996-04-18 |
Recalls involving this device
No recalls on record reference this clearance.