510(k) K063232 ยท CEW Radioimmunoassay, Parathyroid Hormone
ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
| Applicant | Biokit, S.A., Barcelona, ES |
| Decision | Substantially Equivalent, Jun 19, 2007 |
| Received | Oct 25, 2006 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K063232
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 9, 2019 | Abbott Laboratories ARCHITECT Intact PTH Controls - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in human Terminated |
JJX | None listed |
| Apr 9, 2019 | Abbott Laboratories ARCHITECT Intact PTH Calibrators - Product Usage: The ARCHITECT Intact PTH Calibrators are for the calibration of the ARCHITECT iSystem when used for the quantitative determination of Intact PTH in hu Terminated |
JIT | None listed |
| May 29, 2014 | Abbott Laboratories ARCHITECT Intact PTH Calibrators consists of 6 bottles (4.0 mL each). Calibrator A contains Bis Tris Propane buffer with protein (bovine) stabilizer. Calibrators B-F contain PTH (synthetic peptide) in Terminated |
JIT | None listed |
| May 29, 2014 | Abbott Laboratories ARCHITECT Intact PTH Controls consists of 3 x 1 Bottle (8.0 mL each) of PTH (synthetic peptide) in Bis Tris Propane buffer with protein (bovine) stabilizer. Preservatives: sodium azide and ProClin 300 Terminated |
JJX | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.