The following data is part of a premarket notification filed by Metra Biosystems, Inc. with the FDA for Pyrilinks-d Assay Kit.
| Device ID | K952320 |
| 510k Number | K952320 |
| Device Name: | PYRILINKS-D ASSAY KIT |
| Classification | Column Chromatography & Color Development, Hydroxyproline |
| Applicant | METRA BIOSYSTEMS, INC. 14900 SWEITZER LN. SUITE 200 Laurel, MD 20707 |
| Contact | Greg Shippel |
| Correspondent | Greg Shippel METRA BIOSYSTEMS, INC. 14900 SWEITZER LN. SUITE 200 Laurel, MD 20707 |
| Product Code | JMM |
| CFR Regulation Number | 862.1400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-05-18 |
| Decision Date | 1995-12-29 |