510(k) K840011 ยท GKA Abnormal Hemoglobin Quantitation
RESOLVE-HB
| Applicant | Isolab, Inc., Walker MI, US |
| Decision | Substantially Equivalent, Feb 4, 1984 |
| Received | Jan 4, 1984 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K840011
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2004 | PerkinElmer LAS Inc RESOLVE Hemoglobin Test Kits packed and distributed under the Perkin Elmer Life and Analytical Sciences label, Kit Codes: FR-9120 - 120 tests per kit; FR-9400 - 360 tests per kit; and FR-9360 - 360 Terminated |
GKA | None listed |
| Jul 23, 2004 | PerkinElmer LAS Inc RESOLVE Systems Neonatal Hemoglobin Test Kits, 2 Catholyte For in vitro diagnostic use. Terminated |
JBD | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.