Hydragel Iso-Pal K20 (PN 3022); Hydragel 7 Iso-Pal (PN 4112); Hydragel 15 Iso-Pal (PN 4132)
FDA 510(k) K011113 · Sebia
510(k) numberK011113
Submission
- Device name
- Hydragel Iso-Pal K20 (PN 3022); Hydragel 7 Iso-Pal (PN 4112); Hydragel 15 Iso-Pal (PN 4132)
- Applicant
- Sebia
Chelsea, MI, US - Received
- April 11, 2001
- Decision date
- June 13, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIN
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K232904 | Access OstaseCIN · Traditional | Beckman Coulter | 04/15/2024SE |
| K200475 | IDS-iSYS Ostase BAPCIN · Traditional | Immunodiagnostic Systems , Ltd. | 09/30/2020SE |
| K043125 | Orion Diagnostica Uniq Pinp RiaCIN · Traditional | Orion Diagnostica, OY | 05/04/2005SE |
| K020625 | Spife 2000/3000 Alp 40, 20; Models 3345 and 3346CIN · Traditional | Helena Laboratories | 05/06/2002SE |
| K994278 | Access Ostase Immunoenzymetric AssayCIN · Traditional | Beckman Coulter, Inc. | 03/28/2000SE |
| K981373 | Alkphase-B Assay KitCIN · Traditional | Metra Biosystems, Inc. | 05/27/1998SE |
| K972666 | Tandem-Mp Ostase Immunoenzymetric AssayCIN · Traditional | Hybritech, Inc. | 09/11/1997SE |
| K964764 | Opus Bone AlpCIN · Traditional | Behring Diagnostics, Inc. | 01/24/1997SE |
| K961573 | Tandem-R Ostase Immunoradiometric AssayCIN · Traditional | Hybritech, Inc. | 08/19/1996SE |
| K952768 | Alkphase-B Assay KitCIN · Traditional | Metra Biosystems, Inc. | 08/24/1995SE |
More from Metra Biosystems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K232027 | CAPI 3 NEONAT Hb, CAPILLARYS 3 DBS InstrumentGKA · Traditional | 04/04/2024SE |
| K231601 | FLC Kappa, FLC Lambda,FLC Control Level 1, FLC Control Level 2DFH · Traditional | 02/23/2024SE |
| K210623 | FLC Kappa, FLC Lambda, FLC Control Level 1, FLC Control Level 2DFH · Traditional | 11/18/2022SE |
| K203184 | HYDRASHIFT 2/4 isatuximabCFF · Traditional | 11/12/2021SE |
| K192095 | CAPI 3 Immunotyping, Capillarys 3 TeraCFF · Traditional | 11/01/2019SE |
| K190851 | HYDRASHIFT 2/4 daratumumabCFF · Special | 05/02/2019SE |
| K180762 | Capi 3 Hemoglobin(E)GKA · Traditional | 12/14/2018SE |
| K171861 | CAPILLARYS Hb A1cPDJ · Traditional | 02/07/2018SE |
| K172195 | HYDRASHIFT 2/4 daratumumab, daratumumab ControlCFF · Traditional | 01/11/2018SE |
| K171537 | CAPI 3 Hb A1cPDJ · Traditional | 09/12/2017SE |
Questions and answers
When was Hydragel Iso-Pal K20 (PN 3022); Hydragel 7 Iso-Pal (PN 4112); Hydragel 15 Iso-Pal (PN 4132) cleared by the FDA?
Hydragel Iso-Pal K20 (PN 3022); Hydragel 7 Iso-Pal (PN 4112); Hydragel 15 Iso-Pal (PN 4132) (K011113) received a 510(k) decision of Substantially Equivalent on June 13, 2001, 63 days after the submission was received.
What is the product code of K011113?
The FDA product code is CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.