510(k) K050709 ยท GKA Abnormal Hemoglobin Quantitation
RESOLVE HEMOGLOBIN KIT, JB-2 STAINING SYSTEM, MODELS FR-9120, FR-9400, FR-9360, FR-9367
| Applicant | Wallac OY, Turku, FI |
| Decision | Substantially Equivalent, Mar 8, 2006 |
| Received | Mar 18, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050709
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2017 | Perkinelmer Life Sciences, Inc. Multiphor II Electrophoresis System
GE HealthCare Product Number: 18-1018-06
PerkinElmer Part Number: 2117-004
Product Usage:
Multiphor II Electrophoresis System is a versatile modular electr Terminated |
JJN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.