Access Ostase Immunoenzymetric Assay
FDA 510(k) K994278 · Beckman Coulter, Inc.
510(k) numberK994278
Submission
- Device name
- Access Ostase Immunoenzymetric Assay
- Applicant
- Beckman Coulter, Inc.
San Diego, CA, US - Received
- December 20, 1999
- Decision date
- March 28, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
| K011113 | Hydragel Iso-Pal K20 (PN 3022); Hydragel 7 Iso-Pal (PN 4112); Hydragel 15 Iso-Pal (PN…CIN · Traditional | Sebia | 06/13/2001SE |
| 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 |
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|---|---|---|
| K252169 | Access BNP IINBC · Traditional | 03/24/2026SE |
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| K253687 | Access anti-HBc TotalSEI · Traditional | 02/19/2026SE |
| K251995 | Access anti-HAV IgMLOL · Traditional | 01/27/2026SE |
| K250588 | Access Rubella IgGLFX · Traditional | 11/17/2025SE |
| K252580 | iQ200 SeriesLKM · Special | 09/10/2025SE |
| K243846 | Access anti-HAVLOL · Traditional | 09/09/2025SE |
| K243804 | MicroScan Dried Gram-Negative MIC/Combo Panels with Cefepime (CPE) (0.12-64 µg/mL)…LTT · Traditional | 08/20/2025SE |
| K250036 | MicroScan Dried Gram-Positive MIC/Combo Panels with Daptomycin (DAP) (0.06-32 µg/mL)LTT · Traditional | 08/15/2025SE |
| K243483 | Access hsTnIMMI · Traditional | 08/01/2025SE |
Questions and answers
When was Access Ostase Immunoenzymetric Assay cleared by the FDA?
Access Ostase Immunoenzymetric Assay (K994278) received a 510(k) decision of Substantially Equivalent on March 28, 2000, 99 days after the submission was received.
What is the product code of K994278?
The FDA product code is CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.