JMM — Column Chromatography & Color Development, Hydroxyproline Class I
FDA product code JMM covers "Column Chromatography & Color Development, Hydroxyproline", a Class I medical device regulated under 21 CFR 862.1400. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- JMM
- Device Class
- Class I
- Regulation Number
- 862.1400
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K011052 | ostex intl | OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE | July 30, 2001 |
| K993706 | roche diagnostics | ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY | July 24, 2000 |
| K992997 | metrika | OSTEOMARK NTX POC | November 9, 1999 |
| K990843 | osteometer biotech | SERUM CROSSLAPS ONE STEP ELISA | July 9, 1999 |
| K983457 | ostex intl | OSTEOMARK NTX SERUM EIA | February 2, 1999 |
| K983674 | ortho-clinical diagnostics | VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROL | January 29, 1999 |
| K972788 | devices and diagnostics consulting group | CROSSLAPS ELISA | December 22, 1998 |
| K981364 | metra biosystems | PYRILINKS-D ASSAY KIT | August 13, 1998 |
| K980833 | diagnostic products | IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 | May 1, 1998 |
| K980518 | ostex intl | OSTEOMARK | March 6, 1998 |
| K974260 | metra biosystems | PYRILINKS-D ASSAY KIT | January 26, 1998 |
| K972580 | bayer | DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM | September 22, 1997 |
| K971312 | diagnostic products | IMMULITE PYRILINKS-D | May 27, 1997 |
| K963251 | ciba corning diagnostics | CIBA CORNING ACS;180 DPD ASSAY | October 15, 1996 |
| K961562 | ostex intl | OSTEOMARK | July 11, 1996 |
| K960171 | diagnostic systems laboratories | ACTIVE CROSSLAPS ELISA | March 28, 1996 |
| K952320 | metra biosystems | PYRILINKS-D ASSAY KIT | December 29, 1995 |
| K952506 | metra biosystems | PYRILINKS ASSAY KIT | November 3, 1995 |
| K952026 | metra biosystems | PYRILINKS POLYCLONAL ASSAY KIT | November 3, 1995 |
| K945946 | ostex intl | OSTEOMARK(R) | May 8, 1995 |