510(k) K023840
- Device
- ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650
- Applicant
- BAYER DIAGNOSTICS CORP.
- 510(k) number
- K023840
- Product code
- CKB
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2003-01-07
- Date received
- 2002-11-18
- Regulation
- 862.1020
- Classification name
- Acid Phosphatase, Naphthyl Phosphate
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ANDRES HOLLE
- Address
- 511 Benedict Ave. Tarrytown NY US 10591 10591
FDA Registration Numbers#
- 1832216
- 3021841051
- 3016438761
- 3005333358
- 3006198300
- 3004493545
- 2432235
- 1181121
Source Documents#
Other 510(k) Records For Product Code CKB #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K053612 | DRI-STAT ACID PHOSPHATASE REAGENT | Beckman Coulter, Inc. | 2006-04-26 |
| K991010 | ACP | Abbott Diagnostics Mfg., Inc. | 1999-05-19 |
| K981743 | OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | 1998-06-09 |
| K974695 | COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) | Roche Diagnostic Systems, Inc. | 1998-05-21 |
| K963640 | OLYMPUS ACID PHOSPHATASE REAGENT | Olympus America, Inc. | 1997-02-18 |
| K943366 | IL TEST ACID PHOSPHATASE | Instrumentation Laboratory CO | 1996-01-29 |
| K902543 | ACID PHOSPHOTASE REAGENT TEST AND KIT | Crestat Diagnostics, Inc. | 1990-09-07 |
| K902495 | ACID PHOSPHATASE REAGENT SET | Tech Intl. Co. | 1990-07-16 |
| K892393 | ACID PHOSPHATASE REAGENT | Medical Analysis Systems, Inc. | 1989-07-20 |
| K884747 | TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) | Technicon Instruments Corp. | 1989-01-30 |
| K881204 | ACP KINETIC TEST (ACID PHOSPHATASE TEST) | Sclavo, Inc. | 1988-04-28 |
| K880798 | ACID PHOSPHATASE REAGENT | Trace America, Inc. | 1988-04-18 |
| K875209 | ACID PHOSPHATASE (KINETIC) CAT. # 320-06 | Diagnostic Chemicals, Ltd. (Usa) | 1988-02-01 |
| K863851 | ACID PHOSPHATASE (ACP) REAGENT | Sigma Diagnostics, Inc. | 1986-10-16 |
| K861675 | ACID PHOSPHATASE PROCEDURE | Data Medical Associates, Inc. | 1986-05-29 |
Legacy Summary#
summary
FDA Review#
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