Panels › Clinical Chemistry › Product code CKB · Class 2
Acid Phosphatase, Naphthyl Phosphate
Regulation 862.1020
0510(k)s in 12 months (24 all time)
0recalls in 12 months (2 all time)
1recalls that name a 510(k)
Top companies in CKB
| Company | 510(k)s | Recalls |
|---|---|---|
| Data Medical Associates, Inc. | 2 | 0 |
| Olympus America, Inc. | 2 | 0 |
| Abbott Diagnostics Mfg., Inc. | 1 | 0 |
| American Dade | 1 | 0 |
| Bayer Diagnostics Corp. | 1 | 0 |
| Beckman Coulter, Inc. | 1 | 0 |
| Beckman Coulter Mishima K.K. | 0 | 1 |
| Boehringer Mannheim Corp. | 1 | 0 |
| Cooper Biomedical, Inc. | 1 | 0 |
| Crestat Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 26, 2006 | K053612 | DRI-STAT ACID PHOSPHATASE REAGENT Beckman Coulter, Inc. | CKB |
| Jan 7, 2003 | K023840 | ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 Bayer Diagnostics Corp. | CKB |
| May 19, 1999 | K991010 | ACP Abbott Diagnostics Mfg., Inc. | CKB |
| Jun 9, 1998 | K981743 | OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER Olympus America, Inc. | CKB |
| May 21, 1998 | K974695 | COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) Roche Diagnostic Systems, Inc. | CKB |
| Feb 18, 1997 | K963640 | OLYMPUS ACID PHOSPHATASE REAGENT Olympus America, Inc. | CKB |
| Jan 29, 1996 | K943366 | IL TEST ACID PHOSPHATASE Instrumentation Laboratory CO | CKB |
| Sep 7, 1990 | K902543 | ACID PHOSPHOTASE REAGENT TEST AND KIT Crestat Diagnostics, Inc. | CKB |
| Jul 16, 1990 | K902495 | ACID PHOSPHATASE REAGENT SET Tech Intl. Co. | CKB |
| Jul 20, 1989 | K892393 | ACID PHOSPHATASE REAGENT Medical Analysis Systems, Inc. | CKB |
| Jan 30, 1989 | K884747 | TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) Technicon Instruments Corp. | CKB |
| Apr 28, 1988 | K881204 | ACP KINETIC TEST (ACID PHOSPHATASE TEST) Sclavo, Inc. | CKB |
| Apr 18, 1988 | K880798 | ACID PHOSPHATASE REAGENT Trace America, Inc. | CKB |
| Feb 1, 1988 | K875209 | ACID PHOSPHATASE (KINETIC) CAT. # 320-06 Diagnostic Chemicals, Ltd. (Usa) | CKB |
| Oct 16, 1986 | K863851 | ACID PHOSPHATASE (ACP) REAGENT Sigma Diagnostics, Inc. | CKB |
| May 29, 1986 | K861675 | ACID PHOSPHATASE PROCEDURE Data Medical Associates, Inc. | CKB |
| Apr 4, 1986 | K854223 | VES-TEC/VES-MATIC Marvic Interpharma, Inc. | CKB |
| Oct 16, 1985 | K853949 | DEMAND ACID PHOSPHATASE REAGENT Cooper Biomedical, Inc. | CKB |
| Mar 20, 1985 | K850902 | DATA ZYME ACID PHOSPHATASE PROCEDURE Data Medical Associates, Inc. | CKB |
| Apr 4, 1984 | K840661 | PARAMAX ACID PHOSPHATASE REAGENT American Dade | CKB |
| Aug 26, 1983 | K831834 | RAICHEM ACID PHASPHATASE REAGENT Reagents Applications, Inc. | CKB |
| Nov 18, 1982 | K823087 | BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA Boehringer Mannheim Corp. | CKB |
| Jun 22, 1982 | K821674 | SPINCHEM ACID PHOSPHATASE REAGENT Smithkline Diagnostics, Inc. | CKB |
| Apr 26, 1982 | K820975 | GILCHEM ACID PHOSPHATASE REAGENT Gilford Diagnostics | CKB |
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