Panels › Clinical Chemistry › Product code JHG · Class 2
Chromatographic Separation, Lecithin/Sphingomyelin Ratio
Regulation 862.1455
0510(k)s in 12 months (7 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in JHG
| Company | 510(k)s | Recalls |
|---|---|---|
| Hana Biologics, Inc. | 2 | 0 |
| Helena Laboratories | 2 | 0 |
| Abbott Laboratories | 1 | 0 |
| Beckman Instruments, Inc. | 1 | 0 |
| Irvine Scientific Sales Co., Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 18, 2006 | K061549 | AMNIOSTAT-FLM-PG Irvine Scientific Sales Co., Inc. | JHG |
| Jul 20, 1987 | K871593 | TDXR FETAL LUNG MATURITY Abbott Laboratories | JHG |
| May 25, 1984 | K834616 | AMNIO STAT-FLM AGGLUTINATION TEST Hana Biologics, Inc. | JHG |
| Oct 21, 1982 | K822150 | AMNISTAT-FLM Hana Biologics, Inc. | JHG |
| Dec 17, 1981 | K813216 | SECURE FDI TEST KIT Beckman Instruments, Inc. | JHG |
| Jun 25, 1981 | K811588 | HELENA FETAL-TEK 200 METHOD Helena Laboratories | JHG |
| Jun 5, 1979 | K790798 | FETAL MATURITY TEST PROCEDURE Helena Laboratories | JHG |
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