Access Ostase
FDA 510(k) clearance K232904 · decided 2024-04-15
Clearance details
- K-number
- K232904
- Device name
- Access Ostase
- Applicant
- Beckman Coulter
- Decision
- Substantially Equivalent
- Date received
- 2023-09-18
- Decision date
- 2024-04-15
- Days to decision
- 210 days
- Clearance type
- Traditional
- Product code
- CIN
- Device class
- 2
- Regulation number
- 862.1050
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Chaska, MN, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IDS-iSYS Ostase BAP (K200475) | Immunodiagnostic Systems , Ltd. | 2020-09-30 |
| ORION DIAGNOSTICA UNIQ PINP RIA (K043125) | Orion Diagnostica, OY | 2005-05-04 |
| SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 (K020625) | Helena Laboratories | 2002-05-06 |
| HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) (K011113) | Sebia | 2001-06-13 |
| ACCESS OSTASE IMMUNOENZYMETRIC ASSAY (K994278) | Beckman Coulter, Inc. | 2000-03-28 |
| ALKPHASE-B ASSAY KIT (K981373) | Metra Biosystems, Inc. | 1998-05-27 |
| TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY (K972666) | Hybritech, Inc. | 1997-09-11 |
| OPUS BONE ALP (K964764) | Behring Diagnostics, Inc. | 1997-01-24 |
| TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (K961573) | Hybritech, Inc. | 1996-08-19 |
| ALKPHASE-B ASSAY KIT (K952768) | Metra Biosystems, Inc. | 1995-08-24 |
| RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT (K934013) | Isolab, Inc. | 1994-04-26 |
| TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY (K930810) | Hybritech, Inc. | 1994-01-11 |
Recalls involving this device
No recalls on record reference this clearance.