Panels › Hematology › Product code HYI · Class 1
Iodine, Grams
Regulation 864.1850
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 HYI
| Company | 510(k)s | Recalls |
|---|---|---|
| Bioscientific | 1 | 0 |
| Carr-Scarborough Microbiologicals, Inc. | 1 | 0 |
| E K Ind., Inc. | 1 | 0 |
| Granite Diagnostics, Inc. | 1 | 0 |
| Meridian Diagnostics, Inc. | 1 | 0 |
| Remel Co. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 8, 1987 | K871286 | GRAM IODINE Remel Co. | HYI |
| Aug 10, 1984 | K842733 | GRAM IODINE E K Ind., Inc. | HYI |
| Jul 22, 1982 | K821977 | GRAMSTAIN SET Granite Diagnostics, Inc. | HYI |
| Jul 15, 1981 | K811722 | PARA-PAK Meridian Diagnostics, Inc. | HYI |
| Oct 17, 1979 | K791711 | IMPROVED GRAM STAIN REAGENTS Carr-Scarborough Microbiologicals, Inc. | HYI |
| Oct 10, 1978 | K781584 | GRAM STAIN KIT Bioscientific | HYI |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.