CIN — Electrophoretic Separation, Alkaline Phosphatase Isoenzymes Class II
FDA product code CIN covers "Electrophoretic Separation, Alkaline Phosphatase Isoenzymes", a Class II medical device regulated under 21 CFR 862.1050. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CIN
- Device Class
- Class II
- Regulation Number
- 862.1050
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K232904 | beckman coulter | Access Ostase | April 15, 2024 |
| K200475 | immunodiagnostic systems | IDS-iSYS Ostase BAP | September 30, 2020 |
| K043125 | orion diagnostica | ORION DIAGNOSTICA UNIQ PINP RIA | May 4, 2005 |
| K020625 | helena laboratories | SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 | May 6, 2002 |
| K011113 | sebia | HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PA | June 13, 2001 |
| K994278 | beckman coulter | ACCESS OSTASE IMMUNOENZYMETRIC ASSAY | March 28, 2000 |
| K981373 | metra biosystems | ALKPHASE-B ASSAY KIT | May 27, 1998 |
| K972666 | hybritech | TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY | September 11, 1997 |
| K964764 | behring diagnostics | OPUS BONE ALP | January 24, 1997 |
| K961573 | hybritech | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | August 19, 1996 |
| K952768 | metra biosystems | ALKPHASE-B ASSAY KIT | August 24, 1995 |
| K934013 | isolab | RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT | April 26, 1994 |
| K930810 | hybritech | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | January 11, 1994 |
| K921578 | helena laboratories | TITAN GEL ALKALINE PHOSPHATASE (HR) | September 23, 1992 |
| K912603 | helena laboratories | REP ALP-15, 8, & 4 KITS | July 30, 1991 |
| K890269 | beckman instruments | ALKALINE PHOSPHATASE ISOENZYME REAGENTS | March 8, 1989 |
| K885341 | helena laboratories | TITAN GEL ALKALINE PHOSPHATASE (HR) | February 23, 1989 |
| K885024 | ciba corning diagnostics | ALKALINE PHOSPHATASE ISOENZYME SYSTEM | February 17, 1989 |
| K870890 | helena laboratories | ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT | June 1, 1987 |
| K830118 | corning medical and scientific | ALKALINE PHOSPHATES ISOENZYME SUBSTRATE | February 25, 1983 |