Panels › Clinical Chemistry › Product code LFP · Class 2
Conductivity Rate, Urea Nitrogen
Regulation 862.1770
0510(k)s in 12 months (6 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in LFP
| Company | 510(k)s | Recalls |
|---|---|---|
| A-Kem, Inc. | 1 | 0 |
| Amresco, Inc. | 1 | 0 |
| Elan Holdings, Inc. | 1 | 0 |
| Gambro Healthcare | 1 | 0 |
| Sigma Chemical Co. | 1 | 0 |
| Sigma Diagnostics, Inc. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jan 27, 2000 | K990039 | GAMBRO DQM 200 Gambro Healthcare | LFP |
| Oct 14, 1999 | K992847 | HICHEM BUN REAGENT Elan Holdings, Inc. | LFP |
| Oct 24, 1996 | K963537 | SIGMA DIAGNOSTICS BUN REAGENT Sigma Diagnostics, Inc. | LFP |
| Dec 17, 1993 | K933679 | SIGMA BUN REAGENT Sigma Chemical Co. | LFP |
| Oct 23, 1987 | K873132 | BUN REAGENT KIT A-Kem, Inc. | LFP |
| Nov 6, 1981 | K812945 | LIQUILYME BUN REAGENT Amresco, Inc. | LFP |
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