Submission Details
| 510(k) Number | K130698 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 14, 2013 |
| Decision Date | April 05, 2013 |
| Days to Decision | 22 days |
| Submission Type | Abbreviated |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
Cleared
Abbreviated
DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL)
Apr 2013
Decision
22d
Days
Class 2
Risk
About This 510(k) Submission
K130698 is an FDA 510(k) clearance for the DIMENSION VISTA PROGESTERONE CALIBRATOR (PROG CAL), a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on April 5, 2013, 22 days after receiving the submission on March 14, 2013. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.
Device Classification
| Product Code | JIT — Calibrator, Secondary |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1150 |
Manufacturer
Similar Devices — JIT Calibrator, Secondary
All 244
K171168 · Ortho-Clinical Diagnostics
· May 2017
K170938 · Roche Diagnostics
· Apr 2017
K170160 · Abbott Laboratories
· Feb 2017
K163534 · Fujirebio Diagnostics,Inc.
· Jan 2017
K163546 · Fujirebio Diagnostics,Inc.
· Jan 2017
K163521 · Fujirebio Diagnostics,Inc.
· Jan 2017
More from Siemens Healthcare Diagnostics
View all
K243570
· JLW · Apr 2025
K162977
· GKZ · Aug 2017
K162298
· MRG · Mar 2017
K161954
· JGS · Mar 2017
K162538
· JIT · Nov 2016