Panels › Clinical Chemistry › Product code JLX · Class 1
Radioimmunoassay, 17-Hydroxyprogesterone
Regulation 862.1395
0510(k)s in 12 months (19 all time)
0recalls in 12 months (3 all time)
1recalls that name a 510(k)
Top companies in JLX
| Company | 510(k)s | Recalls |
|---|---|---|
| Wallac OY | 5 | 0 |
| Diagnostic Products Corp. | 2 | 0 |
| Diagnostic Systems Laboratories, Inc. | 2 | 0 |
| Siemens Healthcare Diagnostics, Inc. | 0 | 2 |
| Wien Laboratories, Inc. | 2 | 0 |
| Bio-Rad | 1 | 0 |
| DRG International, Inc. | 0 | 1 |
| Drg Intl., Inc. | 1 | 0 |
| Icn Biomedicals, Inc. | 1 | 0 |
| Neo-Genesis | 1 | 0 |
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 29, 2024 | DRG International, Inc. 17-OH Progesterone ELISA 96 well kit- An enzyme immunoassay for the quantitative in vitro diagnostic measurement of 17-OH Progesterone (17-OHP) in serum or plasma
Model/Catalog Number: EIA-1292 Open, Classified |
JLX | None listed |
| May 25, 2023 | Siemens Healthcare Diagnostics, Inc. Atellica CH Toxicology Calibrator (TOX CAL)-The Atellica CH Toxicology Calibrator (TOX CAL) is for in vitro diagnostic use in calibrating the Acet, ETOH and Sal assays using the Atellica CH Analyzer
S Open, Classified |
JLX | None listed |
| May 25, 2023 | Siemens Healthcare Diagnostics, Inc. ADVIA Chemistry ToxAmmonia Calibrator- In vitro diagnostic use in the calibration of ethanol (ETOH_2), ammonia (AMM), acetaminophen (ACET), and salicylate (SAL) assays on the ADVIA Chemistry systems
S Open, Classified |
JLX | K031683 |
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