510(k) K011113
- Device
- HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)
- Applicant
- SEBIA
- 510(k) number
- K011113
- Product code
- CIN
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-06-13
- Date received
- 2001-04-11
- Regulation
- 862.1050
- Classification name
- Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- BOREK JANIK
- Address
- 13805 Waterloo Chelsea MI US 48118 48118
FDA Registration Numbers#
- 9610102
- 2182595
- 8021924
- 8023024
- 1618982
- 1528450
- 3007118747
- 2122870
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CIN #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K232904 | Access Ostase | Beckman Coulter | 2024-04-15 |
| K200475 | IDS-iSYS Ostase BAP | Immunodiagnostic Systems , Ltd. | 2020-09-30 |
| K043125 | ORION DIAGNOSTICA UNIQ PINP RIA | Orion Diagnostica, OY | 2005-05-04 |
| K020625 | SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 | Helena Laboratories | 2002-05-06 |
| K994278 | ACCESS OSTASE IMMUNOENZYMETRIC ASSAY | Beckman Coulter, Inc. | 2000-03-28 |
| K981373 | ALKPHASE-B ASSAY KIT | Metra Biosystems, Inc. | 1998-05-27 |
| K972666 | TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1997-09-11 |
| K964764 | OPUS BONE ALP | Behring Diagnostics, Inc. | 1997-01-24 |
| K961573 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | Hybritech, Inc. | 1996-08-19 |
| K952768 | ALKPHASE-B ASSAY KIT | Metra Biosystems, Inc. | 1995-08-24 |
| K934013 | RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT | Isolab, Inc. | 1994-04-26 |
| K930810 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | Hybritech, Inc. | 1994-01-11 |
| K921578 | TITAN GEL ALKALINE PHOSPHATASE (HR) | Helena Laboratories | 1992-09-23 |
| K912603 | REP ALP-15, 8, & 4 KITS | Helena Laboratories | 1991-07-30 |
| K890269 | ALKALINE PHOSPHATASE ISOENZYME REAGENTS | Beckman Instruments, Inc. | 1989-03-08 |
Legacy Summary#
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FDA Review#
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