Tandem-R Ostase Immunoradiometric Assay
FDA 510(k) K961573 · Hybritech, Inc.
510(k) numberK961573
Submission
- Device name
- Tandem-R Ostase Immunoradiometric Assay
- Applicant
- Hybritech, Inc.
San Diego, CA, US - Received
- April 23, 1996
- Decision date
- August 19, 1996
- 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
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| 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 |
| 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 |
| K952768 | Alkphase-B Assay KitCIN · Traditional | Metra Biosystems, Inc. | 08/24/1995SE |
More from Metra Biosystems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K972666 | Tandem-Mp Ostase Immunoenzymetric AssayCIN · Traditional | 09/11/1997SE |
| K930810 | Tandem-R Ostase Immunoradiometric AssayCIN · Traditional | 01/11/1994SE |
| K922754 | Tandem-E Ige II Calibration Verification SetJJX · Traditional | 02/17/1993SE |
| K921745 | Hybritech Stratus Pap Fluorometric Enzyme ImmunoJFH · Traditional | 07/30/1992SE |
| K921252 | Tandem-E Ferritin Calibration Verification ConrolJJX · Traditional | 07/17/1992SE |
| K920556 | Tandem-E HCG Calibration Verification Control SetJJX · Traditional | 07/17/1992SE |
| K921763 | Tandem Icon QSR CKMB Immunoenzymetric AssayJHY · Traditional | 06/09/1992SE |
| K912439 | Tandem-E TSH Calibration Verification Control SetJJX · Traditional | 08/28/1991SE |
| K911417 | Icon Strep B Immunoenzymetric AssayGTZ · Traditional | 07/24/1991SE |
| K902991 | Icon Strep B Immunoenzymetric AssayGTY · Traditional | 10/03/1990SE |
Questions and answers
When was Tandem-R Ostase Immunoradiometric Assay cleared by the FDA?
Tandem-R Ostase Immunoradiometric Assay (K961573) received a 510(k) decision of Substantially Equivalent on August 19, 1996, 118 days after the submission was received.
What is the product code of K961573?
The FDA product code is CIN – Electrophoretic Separation, Alkaline Phosphatase Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.