510(k) K020138 ยท KHG Whole Blood Hemoglobin Determination
STAT-SITE MHGB METER, STAT-SITE MHGB METER CARD HOLDER, STAT-SITE MHGB TEST CARDS, STAT-SITE MHGB CODE WAY, MODELS 90090
| Applicant | Gds Technology, Elkhart IN, US |
| Decision | Substantially Equivalent, Feb 11, 2002 |
| Received | Jan 16, 2002 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K020138
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.