Pyrilinks-D Assay Kit
FDA 510(k) K981364 · Metra Biosystems, Inc.
510(k) numberK981364
Submission
- Device name
- Pyrilinks-D Assay Kit
- Applicant
- Metra Biosystems, Inc.
Mountain View, CA, US - Received
- April 15, 1998
- Decision date
- August 13, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
| K980833 | Immulite Pyrilinks-D Model Numbers LKPD1, LKPD5JMM · Traditional | Diagnostic Products Corp. | 05/01/1998SE |
| K980518 | OsteomarkJMM · Traditional | Ostex Intl., Inc. | 03/06/1998SE |
| K974260 | Pyrilinks-D Assay KitJMM · Traditional | Metra Biosystems, Inc. | 01/26/1998SE |
More from Metra Biosystems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981373 | Alkphase-B Assay KitCIN · Traditional | 05/27/1998SE |
| K974260 | Pyrilinks-D Assay KitJMM · Traditional | 01/26/1998SE |
| K952320 | Pyrilinks-D Assay KitJMM · Traditional | 12/29/1995SE |
| K952506 | Pyrilinks Assay KitJMM · Traditional | 11/03/1995SE |
| K952026 | Pyrilinks Polyclonal Assay KitJMM · Traditional | 11/03/1995SE |
| K952768 | Alkphase-B Assay KitCIN · Traditional | 08/24/1995SE |
Questions and answers
When was Pyrilinks-D Assay Kit cleared by the FDA?
Pyrilinks-D Assay Kit (K981364) received a 510(k) decision of Substantially Equivalent on August 13, 1998, 120 days after the submission was received.
What is the product code of K981364?
The FDA product code is JMM – Column Chromatography & Color Development, Hydroxyproline, a Class I (low risk) device regulated under 21 CFR 862.1400.