Panels › Clinical Chemistry › Product code CEX · Class 2
Chromatographic Separation, Lactate Dehydrogenase Isoenzymes
Regulation 862.1445
0510(k)s in 12 months (8 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in CEX
| Company | 510(k)s | Recalls |
|---|---|---|
| Berwick Medical Products, Inc. | 1 | 0 |
| Bio-Reagents & Diagnostics, Inc. | 1 | 0 |
| Data Medical Associates, Inc. | 1 | 0 |
| Harleco Diagnostics | 1 | 0 |
| Helena Laboratories | 1 | 0 |
| Seragen Diagnostics, Inc. | 1 | 0 |
| Union Carbide Corp. | 1 | 0 |
| Worthington Biochemical Corp. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 16, 1987 | K872891 | LACTATE DEHYDROGENASE ISOENZYME 1 Data Medical Associates, Inc. | CEX |
| May 10, 1985 | K851521 | LD-1(IMMUNO) SEPARATION SET Seragen Diagnostics, Inc. | CEX |
| Sep 28, 1984 | K842018 | ISO-SEP SYSTEM Berwick Medical Products, Inc. | CEX |
| Dec 22, 1982 | K821983 | TITAN GEL LDH ISOENZYME KIT Helena Laboratories | CEX |
| Jul 14, 1982 | K821879 | ULTRACHEM T.P. Harleco Diagnostics | CEX |
| Feb 13, 1980 | K800129 | CENTRIFICHEM CREATININE Union Carbide Corp. | CEX |
| Jan 24, 1978 | K772356 | LDH ISOENZYME COLUMN REAGENT SET Worthington Biochemical Corp. | CEX |
| Dec 22, 1977 | K771894 | LDH ISOENZYME CONTROL Bio-Reagents & Diagnostics, Inc. | CEX |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.