Product code CIN
- Device name
- Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1050
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 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 |
| K011113 | HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) | Sebia | 2001-06-13 |
| 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 |
| K885341 | TITAN GEL ALKALINE PHOSPHATASE (HR) | Helena Laboratories | 1989-02-23 |
| K885024 | ALKALINE PHOSPHATASE ISOENZYME SYSTEM | Ciba Corning Diagnostics Corp. | 1989-02-17 |
| K870890 | ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT | Helena Laboratories | 1987-06-01 |
| K830118 | ALKALINE PHOSPHATES ISOENZYME SUBSTRATE | Corning Medical & Scientific | 1983-02-25 |
| K823445 | ALKPHOR SYSTEM | California Immuno Diagnostic, Inc. | 1982-12-28 |
| K810144 | ALK-PHOS BIOPAK GEL | Bioware Products | 1981-02-02 |
| K792548 | ALKALINE PHOSPHATASE MARKER | Electrophoresis Corp. of America | 1980-01-29 |
| K771620 | ALKALINE PHOSPHATASE ISOENZY. SUB. SET | Pfizer, Inc. | 1977-09-15 |
| K771225 | AP ISOTROL, #A 0140 | Sigma Chemical Co. | 1977-08-03 |
| K760862 | PROCEDURE NO. 710-EP FOR ALK.PHOS. | Sigma Chemical Co. | 1976-11-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 05060169695801 | IDS-iSYS Ostase® BAP | IMMUNODIAGNOSTIC SYSTEMS LIMITED | 2021-03-08 |
| 30014613333920 | MicroVue | QUIDEL CORPORATION | 2016-09-15 |
| 15099590232313 | Access Ostase | Beckman Coulter, Inc. | 2016-09-09 |
| M52530580 | TITAN GEL Alkaline Phosphatase Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52533480 | SPIFE ALP Separation Enhancer | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M52551020 | Alkaline Phosphatase Indolyl Blue Reagent Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M5255510310 | TITAN GEL Alkaline Phosphatase Reagent Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M5255520550 | SPIFE Alkaline Phosphatase Reagent Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M5255523950 | SPIFE Alkaline Phosphatase-20,40 Gel Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| M5255526040 | SPIFE Alkaline Phosphatase Gel Kit | HELENA LABORATORIES CORPORATION | 2016-09-07 |
| 06438115000082 | UniQ® PINP RIA | Aidian Oy | 2016-04-13 |
| 05060169690059 | Ostase®+ BAP EIA | IMMUNODIAGNOSTIC SYSTEMS LIMITED | 2016-04-01 |