Cobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra Benzodiazepines with B-Glucuronidase (Bnzgl)
FDA 510(k) K974695 · Roche Diagnostic Systems, Inc.
510(k) numberK974695
Submission
- Device name
- Cobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra Benzodiazepines with B-Glucuronidase (Bnzgl)
- Applicant
- Roche Diagnostic Systems, Inc.
Branchburg, NJ, US - Received
- December 16, 1997
- Decision date
- May 21, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CKB – Acid Phosphatase, Naphthyl Phosphate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1020
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CKB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K053612 | Dri-Stat Acid Phosphatase ReagentCKB · Traditional | Beckman Coulter, Inc. | 04/26/2006SE |
| K023840 | Acid Phosphatase Assay for the Advia 1650CKB · Traditional | Bayer Diagnostics Corp. | 01/07/2003SE |
| K991010 | AcpCKB · Traditional | Abbott Diagnostics Mfg., Inc. | 05/19/1999SE |
| K981743 | Olympus AU400 Clinical Chemistry AnalyzerCKB · Special | Olympus America, Inc. | 06/09/1998SE |
| K963640 | Olympus Acid Phosphatase ReagentCKB · Traditional | Olympus America, Inc. | 02/18/1997SE |
| K943366 | Il Test Acid PhosphataseCKB · Traditional | Instrumentation Laboratory CO | 01/29/1996SE |
| K902543 | Acid Phosphotase Reagent Test and KitCKB · Traditional | Crestat Diagnostics, Inc. | 09/07/1990SE |
| K902495 | Acid Phosphatase Reagent SetCKB · Traditional | Tech Intl. Co. | 07/16/1990SE |
| K892393 | Acid Phosphatase ReagentCKB · Traditional | Medical Analysis Systems, Inc. | 07/20/1989SE |
| K884747 | Technicon Chem 1 System Acid Phosphatase (Total)CKB · Traditional | Technicon Instruments Corp. | 01/30/1989SE |
More from Technicon Instruments Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K983698 | Modification to Abuscreen Online BarbituratesDIS · Traditional | 05/03/1999SE |
| K983702 | Modification to Abuscreen Online for BenzoidiazepinesJXM · Traditional | 02/11/1999SE |
| K983704 | Modification to Abuscreen Online for PhencyclidineJCM · Traditional | 02/10/1999SE |
| K983556 | Abuscreen Online Benz 300 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983555 | Abuscreen Online Benz 200 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983703 | Modification to Abuscreen Online for MethadoneDJR · Special | 12/11/1998SE |
| K983701 | Modification to Abuscreen Online for CannabinoidsLDJ · Special | 12/11/1998SE |
| K983700 | Modification to Abuscreen Online for PropoxypheneJXN · Special | 12/11/1998SE |
| K983699 | Modification to Abuscreen Online for AmphetaminesDKZ · Special | 12/11/1998SE |
| K983697 | Modification to Abuscreen Online Cocaine MetaboliteDIO · Special | 12/11/1998SE |
Questions and answers
When was Cobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra Benzodiazepines with B-Glucuronidase (Bnzgl) cleared by the FDA?
Cobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra Benzodiazepines with B-Glucuronidase (Bnzgl) (K974695) received a 510(k) decision of Substantially Equivalent on May 21, 1998, 156 days after the submission was received.
What is the product code of K974695?
The FDA product code is CKB – Acid Phosphatase, Naphthyl Phosphate, a Class II (moderate risk) device regulated under 21 CFR 862.1020.