VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS
FDA 510(k) clearance K983674 · decided 1999-01-29
Clearance details
- K-number
- K983674
- Device name
- VITROS IMMUNODIAGNOSTIC PRODUCTS: NTX CALIBRATORS, NTX REAGENT PACK, NTX CONTROLS
- Applicant
- Ortho-Clinical Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1998-10-20
- Decision date
- 1999-01-29
- Days to decision
- 101 days
- Clearance type
- Traditional
- Product code
- JMM
- Device class
- 1
- Regulation number
- 862.1400
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Rochester, NY, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| OSTEOMARK NTX POINT OF CARE PRESCRIPTION HOME USE (K011052) | Ostex Intl., Inc. | 2001-07-30 |
| ELECSYS SERUM B-CROSSLAPS/SERUM IMMUNOASSAY (K993706) | Roche Diagnostics Corp. | 2000-07-24 |
| OSTEOMARK NTX POC (K992997) | Metrika, Inc. | 1999-11-09 |
| SERUM CROSSLAPS ONE STEP ELISA (K990843) | Osteometer Biotech A/S | 1999-07-09 |
| OSTEOMARK NTX SERUM EIA (K983457) | Ostex Intl., Inc. | 1999-02-02 |
| CROSSLAPS ELISA (K972788) | Devices and Diagnostics Consulting Group | 1998-12-22 |
| PYRILINKS-D ASSAY KIT (K981364) | Metra Biosystems, Inc. | 1998-08-13 |
| IMMULITE PYRILINKS-D MODEL NUMBERS LKPD1, LKPD5 (K980833) | Diagnostic Products Corp. | 1998-05-01 |
| OSTEOMARK (K980518) | Ostex Intl., Inc. | 1998-03-06 |
| PYRILINKS-D ASSAY KIT (K974260) | Metra Biosystems, Inc. | 1998-01-26 |
| DEOXYPYRIDINOLINE ASSAY FOR THE BAYER IMMUNO 1 SYSTEM (K972580) | Bayer Corp. | 1997-09-22 |
| IMMULITE PYRILINKS-D (K971312) | Diagnostic Products Corp. | 1997-05-27 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| VITROS Anti-HBc IgM (P030026/S037) | Ortho-Clinical Diagnostics, Inc. | 2023-01-24 |
| VITROS Immunodiagnostic Products HBeAg Reagent Pack and Calibrator (P090028/S018) | Ortho-Clinical Diagnostics, Inc. | 2023-01-24 |
| VITROS Immunodiagnostic Products Anti-HBs Quantitative Reagent Pack and Calibrator (P000014/S036) | Ortho-Clinical Diagnostics, Inc. | 2020-10-22 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S033) | Ortho-Clinical Diagnostics, Inc. | 2020-08-07 |
| VITROS Anti-HBs (P000014/S035) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator (P010021/S032) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS Anti-HBc IgM (P030026/S036) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |
| VITROS HBeAg (P090028/S017) | Ortho-Clinical Diagnostics, Inc. | 2019-06-19 |