Panels › Clinical Chemistry › Product code JHF · Class 2
Colorimetric Method, Lecithin/Sphingomyelin Ratio
Regulation 862.1455
0510(k)s in 12 months (2 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in JHF
| Company | 510(k)s | Recalls |
|---|---|---|
| Abbott Laboratories | 1 | 0 |
| Isolab, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Feb 8, 1995 | K940817 | TDX(R)/TDXFLX(R) FETAL LUNG MATURITY II Abbott Laboratories | JHF |
| Mar 15, 1989 | K883411 | PG-NUMERIC(TM) Isolab, Inc. | JHF |
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