Panels › Hematology › Product code GIG · Class 2
Hemoglobinometer
Regulation 864.7500
0510(k)s in 12 months (3 all time)
0recalls in 12 months (0 all time)
0recalls that name a 510(k)
Top companies in GIG
| Company | 510(k)s | Recalls |
|---|---|---|
| Artel, Inc. | 1 | 0 |
| The Dow Chemical Co. | 1 | 0 |
| Randox Laboratories, Ltd. | 1 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 8, 1997 | K973995 | RANDOX BILIRUBIN Randox Laboratories, Ltd., IE | GIG |
| Mar 31, 1994 | K933836 | HBM HEMOGLOBINOMETER Artel, Inc. | GIG |
| Jul 21, 1977 | K771101 | HEMOGLOBIN ANALYZER & PERFORM. CHECK SET The Dow Chemical Co. | GIG |
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