Company ยท US
Michclone Associates, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 1987. Name variants (Inc, Corp, punctuation) are merged.
3510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
3recalls that name a 510(k)
Product codes
Latest 510(k) clearances
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| 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 | K860812 |
| 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 | K860812 |
| 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 | K860812 |