510(k) K063232
- Device
- ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
- Applicant
- BIOKIT S.A.
- 510(k) number
- K063232
- Product code
- CEW
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2007-06-19
- Date received
- 2006-10-25
- Regulation
- 862.1545
- Classification name
- Radioimmunoassay, Parathyroid Hormone
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JOAN GUIXER
- Address
- Can Male Llissa D'Amunt Barcelona ES 08186 08186
FDA Registration Numbers#
- 3006198300
- 3002800697
- 9680746
- 2245285
- 3005333358
- 2432235
- 2025099
- 3022178699
- 3012963943
- 2250051
- 8023018
- 3002809144
- 2182595
- 9612316
- 3007118747
- 2020726
- 1222302
- 3009518015
- 1036362
- 2517506
- 2122870
- 8031673
- 3011989923
- 9610746
- 3033967997
- 3002642396
- 8020888
- 1219913
- 3005529799
- 3007111389
- 9610126
- 1319681
- 8021924
- 3000308930
- 3002806944
- 2032839
Source Documents#
Other 510(k) Records For Product Code CEW #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K231927 | Elecsys PTH , Elecsys PTH STAT | Roche Diagnostics | 2024-03-22 |
| K232791 | Access Intact PTH | Beckman Coulter, Inc. | 2024-03-01 |
| K221197 | VITROS Immunodiagnostic Products Intact PTH II Reagent Pack | Ortho Clinical Diagnostics | 2023-09-05 |
| K190702 | Lumipulse G whole PTH | Fujirebio Diagnostics,Inc. | 2019-08-30 |
| K163658 | ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay | Siemens Healthcare Diagnostics, Inc. | 2017-05-23 |
| K161158 | IDS-iSYS Intact PTHN | Immunodiagnostic Systems , Ltd. | 2017-01-31 |
| K150879 | LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration Verifiers | DiaSorin, Inc. | 2015-06-22 |
| K133601 | ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY | Siemens Healthcare Diagnostics, Inc. | 2014-02-05 |
| K132515 | LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS | DiaSorin, Inc. | 2013-11-08 |
| K121981 | ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY | Siemens Healthcare Diagnostics | 2013-03-21 |
| K103325 | IDS-ISYS INTACT PTH | Immunodiagnostic Systems , Ltd. | 2012-02-03 |
| K101921 | VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH REAGENT PACK, VITROS IMMUNODIAGNOSTICS PRODUCTS INTACT PTH CALIBRATORS, VIT | Ortho-Clinical Diagnostics | 2010-10-22 |
| K070709 | ROCHE ELECSYS PTH TEST SYSTEM | Roche Diagnostics Corp. | 2007-07-13 |
| K063605 | ST AIA-PACK INTACT PTH ASSAY | Tosoh Bioscience, Inc. | 2007-06-21 |
| K070391 | ELECSYS PTH TEST SYSTEM | Roche Diagnostics Corp. | 2007-03-20 |
Legacy Summary#
summary
FDA Review#
Decision Summary