FDA Product Code
FDA Product Code CKB — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1020
510(k) Clearances — 24 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K053612 | DRI-STAT ACID PHOSPHATASE REAGENT | Beckman Coulter, Inc. | 2006-04-26 | Traditional | PDF ↗ |
| K023840 | ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 | Bayer Diagnostics Corp. | 2003-01-07 | Traditional | PDF ↗ |
| K991010 | ACP | Abbott Diagnostics Mfg., Inc. | 1999-05-19 | Traditional | PDF ↗ |
| K981743 | OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | 1998-06-09 | Special | PDF ↗ |
| K974695 | COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) | Roche Diagnostic Systems, Inc. | 1998-05-21 | Traditional | PDF ↗ |
| K963640 | OLYMPUS ACID PHOSPHATASE REAGENT | Olympus America, Inc. | 1997-02-18 | Traditional | PDF ↗ |
| K943366 | IL TEST ACID PHOSPHATASE | Instrumentation Laboratory CO | 1996-01-29 | Traditional | PDF ↗ |
| K902543 | ACID PHOSPHOTASE REAGENT TEST AND KIT | Crestat Diagnostics, Inc. | 1990-09-07 | Traditional | PDF ↗ |
| K902495 | ACID PHOSPHATASE REAGENT SET | Tech Intl. Co. | 1990-07-16 | Traditional | PDF ↗ |
| K892393 | ACID PHOSPHATASE REAGENT | Medical Analysis Systems, Inc. | 1989-07-20 | Traditional | PDF ↗ |
| K884747 | TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) | Technicon Instruments Corp. | 1989-01-30 | Traditional | PDF ↗ |
| K881204 | ACP KINETIC TEST (ACID PHOSPHATASE TEST) | Sclavo, Inc. | 1988-04-28 | Traditional | PDF ↗ |
| K880798 | ACID PHOSPHATASE REAGENT | Trace America, Inc. | 1988-04-18 | Traditional | PDF ↗ |
| K875209 | ACID PHOSPHATASE (KINETIC) CAT. # 320-06 | Diagnostic Chemicals, Ltd. (Usa) | 1988-02-01 | Traditional | PDF ↗ |
| K863851 | ACID PHOSPHATASE (ACP) REAGENT | Sigma Diagnostics, Inc. | 1986-10-16 | Traditional | PDF ↗ |
| K861675 | ACID PHOSPHATASE PROCEDURE | Data Medical Associates, Inc. | 1986-05-29 | Traditional | PDF ↗ |
| K854223 | VES-TEC/VES-MATIC | Marvic Interpharma, Inc. | 1986-04-04 | Traditional | PDF ↗ |
| K853949 | DEMAND ACID PHOSPHATASE REAGENT | Cooper Biomedical, Inc. | 1985-10-16 | Traditional | PDF ↗ |
| K850902 | DATA ZYME ACID PHOSPHATASE PROCEDURE | Data Medical Associates, Inc. | 1985-03-20 | Traditional | PDF ↗ |
| K840661 | PARAMAX ACID PHOSPHATASE REAGENT | American Dade | 1984-04-04 | Traditional | PDF ↗ |
| K831834 | RAICHEM ACID PHASPHATASE REAGENT | Reagents Applications, Inc. | 1983-08-26 | Traditional | PDF ↗ |
| K823087 | BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA | Boehringer Mannheim Corp. | 1982-11-18 | Traditional | PDF ↗ |
| K821674 | SPINCHEM ACID PHOSPHATASE REAGENT | Smithkline Diagnostics, Inc. | 1982-06-22 | Traditional | PDF ↗ |
| K820975 | GILCHEM ACID PHOSPHATASE REAGENT | Gilford Diagnostics | 1982-04-26 | Traditional | PDF ↗ |
Product code CKB · Class II · Clinical Chemistry. Data: openFDA.