Data / Medical devices / United States / Michclone Associates, Inc.
Michclone Associates, Inc.: FDA-registered device maker in Troy, MI, United States, 2 510(k) clearances
Michclone Associates, Inc. is registered with the FDA (registration 1831312) in Troy, MI, United States. It lists 4 device types. The FDA files 2 510(k) clearances under its listings, the newest dated April 11, 1986. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1831312
- Address
- 1713 Larchwood Dr STE B, Troy, MI, United States, 48083
- Owner or operator
- MICHCLONE ASSOCIATES, INC. (1831312)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- November 22, 1992
- Registered through
- 2026
- Brand names listed
- Alcoholic Formalin, B-5 Fixative, Blood Bank Saline Solution, Bouin's Fixative, Buffered Zinc Formalin, Carson's Modified Millonigs Formalin, Hemoglobin M, Neutral Buffered Formalin and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Fixative, Formalin-Containing | LDY | 1 | Manufacturer | accessdata.fda.gov |
| Fixative, Metallic Containing | LDX | 1 | Manufacturer | accessdata.fda.gov |
| Solution, Isotonic | JCE | 1 | Manufacturer | accessdata.fda.gov |
| Test, Sickle Cell | GHM | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| April 11, 1986 | K860812 | SICKLE CELL REAGENT SET | GHM | Substantially Equivalent | Michclone Associates, Inc. | accessdata.fda.gov |
| August 9, 1984 | K842955 | SICKLE-HEME A/S HETEROZYGOUS CONTROL | GHM | Substantially Equivalent | Michclone Associates, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| February 23, 2012 | 61384 | Not yet classified | Terminated | 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 Powder; One Line Scale Tw | Michclone Associate's has received two complaints concerning the powder vial included in the 100 test kit observed producing pressure while sealed. When the powders are opened, the pressure from within the vial releases a small amount of powder into the air. This powder. if released near the face and inhaled can cause minor irritation resulting in sneezing a | accessdata.fda.gov |
Compare with other makers
- All makers of Solution, Isotonic
- All makers of Fixative, Formalin-Containing
- All makers of Test, Sickle Cell
- All makers of Fixative, Metallic Containing
Updated May 9, 2012. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.