510(k) K860812 ยท GHM Test, Sickle Cell
SICKLE CELL REAGENT SET
| Applicant | Michclone Associates, Inc., Detroit MI, US |
| Decision | Substantially Equivalent, Apr 11, 1986 |
| Received | Mar 4, 1986 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K860812
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 9, 2012 | MichClone Associates, Inc. Sickle Heme, Hemoglobin S Solubility For Qualitative Determination of Hemoglobin S Test; ,100 Test Kit Product, No MCA 100, Contents: Two bottles of Sickle Cell Buffer, Two Bottles of Sickle Cell Powd Terminated |
GHM | None listed |
| May 9, 2012 | MichClone Associates, Inc. BioTron Sickle Cell Reagent Set, Screening test for the Presence of Hemoglobin S 2 x 100 ml Sickle Cell Buffer, 2 vials sickle Cell Reagent, Size 100 tests, Store 2-8 C, BioTron Diagnostics Inc, Hemet Terminated |
GHM | None listed |
| May 9, 2012 | MichClone Associates, Inc. Sickle- Scan Hemoglobin S Cell Reagent Set, Catalog No. 13-2101 100 Tests For the Determination of Hemoglobin S Two bottles Sickle Cell Solubility Buffer, 100 ml , 2 vials Sickle Cell Solubility Powde Terminated |
GHM | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.