Active Crosslaps Elisa
FDA 510(k) K960171 · Diagnostic Systems Laboratories, Inc.
510(k) numberK960171
Submission
- Device name
- Active Crosslaps Elisa
- Applicant
- Diagnostic Systems Laboratories, Inc.
Webster, TX, US - Received
- January 16, 1996
- Decision date
- March 28, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JMM – Column Chromatography & Color Development, Hydroxyproline
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1400
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JMM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011052 | Osteomark NTX Point of Care Prescription Home UseJMM · Traditional | Ostex Intl., Inc. | 07/30/2001SE |
| K993706 | Elecsys Serum B-Crosslaps/Serum ImmunoassayJMM · Traditional | Roche Diagnostics Corp. | 07/24/2000SE |
| K992997 | Osteomark NTX PocJMM · Traditional | Metrika, Inc. | 11/09/1999SE |
| K990843 | Serum Crosslaps One Step ElisaJMM · Traditional | Osteometer Biotech A/S | 07/09/1999SE |
| K983457 | Osteomark NTX Serum EiaJMM · Traditional | Ostex Intl., Inc. | 02/02/1999SE |
| K983674 | Vitros Immunodiagnostic Products: NTX Calibrators, NTX Reagent Pack, NTX ControlsJMM · Traditional | Ortho-Clinical Diagnostics, Inc. | 01/29/1999SE |
| K972788 | Crosslaps ElisaJMM · Traditional | Devices and Diagnostics Consulting Group | 12/22/1998SE |
| K981364 | Pyrilinks-D Assay KitJMM · Traditional | Metra Biosystems, Inc. | 08/13/1998SE |
| K980833 | Immulite Pyrilinks-D Model Numbers LKPD1, LKPD5JMM · Traditional | Diagnostic Products Corp. | 05/01/1998SE |
| K980518 | OsteomarkJMM · Traditional | Ostex Intl., Inc. | 03/06/1998SE |
More from Ostex Intl., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K061758 | Active Renin IrmaCIB · Special | 07/28/2006SE |
| K020945 | Axsym Intact PTH, Model 2G06CEW · Traditional | 05/31/2002SE |
| K020128 | Active Free Beta-Hcg Elisa, Model DSL-10-8500JHI · Traditional | 03/01/2002SE |
| K002128 | Active Inhibin-A Elisa, Model DSL-10-28100NDR · Traditional | 12/05/2000SE |
| K001086 | Free Testosterone Enzyme Immunoassay, Model DSL-10-4900CDZ · Traditional | 05/18/2000SE |
| K990138 | DSL Active Afp Elisa, Model DSL-10-8400LOJ · Traditional | 06/21/1999SE |
| K981871 | C-Reactive Protein Elisa, Model Number DSL-10-42100DCK · Traditional | 11/09/1998SE |
| K973244 | Active Psa Irma (DSL-9700)LTJ · Traditional | 08/03/1998SE |
| K973243 | Active Psa Elisa (DSL-10-9700)LTJ · Traditional | 08/03/1998SE |
| K981607 | Active Renin Irma Model Number DSL-25100CIB · Traditional | 05/27/1998SE |
Questions and answers
When was Active Crosslaps Elisa cleared by the FDA?
Active Crosslaps Elisa (K960171) received a 510(k) decision of Substantially Equivalent on March 28, 1996, 72 days after the submission was received.
What is the product code of K960171?
The FDA product code is JMM – Column Chromatography & Color Development, Hydroxyproline, a Class I (low risk) device regulated under 21 CFR 862.1400.