FDA Product Code
FDA Product Code CIN — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1050
510(k) Clearances — 26 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K232904 | Access Ostase | Beckman Coulter | 2024-04-15 | Traditional | PDF ↗ |
| K200475 | IDS-iSYS Ostase BAP | Immunodiagnostic Systems , Ltd. | 2020-09-30 | Traditional | PDF ↗ |
| K043125 | ORION DIAGNOSTICA UNIQ PINP RIA | Orion Diagnostica, OY | 2005-05-04 | Traditional | PDF ↗ |
| K020625 | SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346 | Helena Laboratories | 2002-05-06 | Traditional | PDF ↗ |
| K011113 | HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132) | Sebia | 2001-06-13 | Traditional | PDF ↗ |
| K994278 | ACCESS OSTASE IMMUNOENZYMETRIC ASSAY | Beckman Coulter, Inc. | 2000-03-28 | Traditional | PDF ↗ |
| K981373 | ALKPHASE-B ASSAY KIT | Metra Biosystems, Inc. | 1998-05-27 | Traditional | PDF ↗ |
| K972666 | TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAY | Hybritech, Inc. | 1997-09-11 | Traditional | PDF ↗ |
| K964764 | OPUS BONE ALP | Behring Diagnostics, Inc. | 1997-01-24 | Traditional | PDF ↗ |
| K961573 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | Hybritech, Inc. | 1996-08-19 | Traditional | PDF ↗ |
| K952768 | ALKPHASE-B ASSAY KIT | Metra Biosystems, Inc. | 1995-08-24 | Traditional | PDF ↗ |
| K934013 | RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT | Isolab, Inc. | 1994-04-26 | Traditional | PDF ↗ |
| K930810 | TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY | Hybritech, Inc. | 1994-01-11 | Traditional | PDF ↗ |
| K921578 | TITAN GEL ALKALINE PHOSPHATASE (HR) | Helena Laboratories | 1992-09-23 | Traditional | PDF ↗ |
| K912603 | REP ALP-15, 8, & 4 KITS | Helena Laboratories | 1991-07-30 | Traditional | PDF ↗ |
| K890269 | ALKALINE PHOSPHATASE ISOENZYME REAGENTS | Beckman Instruments, Inc. | 1989-03-08 | Traditional | PDF ↗ |
| K885341 | TITAN GEL ALKALINE PHOSPHATASE (HR) | Helena Laboratories | 1989-02-23 | Traditional | PDF ↗ |
| K885024 | ALKALINE PHOSPHATASE ISOENZYME SYSTEM | Ciba Corning Diagnostics Corp. | 1989-02-17 | Traditional | PDF ↗ |
| K870890 | ALKALINE PHOSPHATASE INDOLYL BLUE REAGENT | Helena Laboratories | 1987-06-01 | Traditional | PDF ↗ |
| K830118 | ALKALINE PHOSPHATES ISOENZYME SUBSTRATE | Corning Medical & Scientific | 1983-02-25 | Traditional | PDF ↗ |
| K823445 | ALKPHOR SYSTEM | California Immuno Diagnostic, Inc. | 1982-12-28 | Traditional | PDF ↗ |
| K810144 | ALK-PHOS BIOPAK GEL | Bioware Products | 1981-02-02 | Traditional | PDF ↗ |
| K792548 | ALKALINE PHOSPHATASE MARKER | Electrophoresis Corp. of America | 1980-01-29 | Traditional | PDF ↗ |
| K771620 | ALKALINE PHOSPHATASE ISOENZY. SUB. SET | Pfizer, Inc. | 1977-09-15 | Traditional | PDF ↗ |
| K771225 | AP ISOTROL, #A 0140 | Sigma Chemical Co. | 1977-08-03 | Traditional | PDF ↗ |
| K760862 | PROCEDURE NO. 710-EP FOR ALK.PHOS. | Sigma Chemical Co. | 1976-11-02 | Traditional | PDF ↗ |
Product code CIN · Class II · Clinical Chemistry. Data: openFDA.