Skip to content

Michclone Associates, Inc.

United Statesfrom the FDA registration address FDA establishment FEI 1831312

Devices
3
Registrations
FDA
FDA recalls
3

What Michclone Associates, Inc. makes

Michclone Associates, Inc. makes reagent sets for sickle cell testing and enzymatic cholesterol testing, as well as a sickle-heme A/S heterozygous control.

The company's devices are classified as Class I and Class II and are listed in the FDA 510(k) registry; the company is based in the United States.

AI-generated from registry data, 26 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue3

Newest first, rows 1-3 of 3

Company details

FDA FEI number
1831312
Address
1713 Larchwood Dr, Troy, MI, 48083

FDA recalls3

Recalls are matched to the firm by name. FDA recall data as of 22 Oct 2026.

FDA recall records list 3 recalls initiated by MICHCLONE ASSOCIATES, INC., initiated on 2012-02-23. By recorded status: 3 terminated. The reasons filed fall into these groups: packaging. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.

Generated automatically from FDA recall records, as a summary of the records listed below. It describes what the records state and is not an assessment of this manufacturer.

  • 2012

    • 23 Feb 2012 Z-1501-2012 Not yet classified Terminated 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 and nasal congestion. Investigation f Distribution: Nationwide Distribution. Submission number: K860812
    • 23 Feb 2012 Z-1502-2012 Not yet classified Terminated Two complaints received 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 and nasal congestion. Investigation found no affect on the perf Distribution: Nationwide Distribution. Submission number: K860812
    • 23 Feb 2012 Z-1503-2012 Not yet classified Terminated Two complaints concerning the powder vial included in the 100 test kit has been 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 and nasal congestion. Investigation found no affect on the perf Distribution: Nationwide Distribution. Submission number: K860812

Frequently asked questions

How many devices does MICHCLONE ASSOCIATES, INC. have in the registry?

The registry currently lists 3 devices for MICHCLONE ASSOCIATES, INC.. Devices recorded under merged duplicate company entries are counted once.

Which registries list MICHCLONE ASSOCIATES, INC.'s devices?

Among its 3 most recently registered devices, MICHCLONE ASSOCIATES, INC. has devices listed in FDA 510(k) (3 devices).

What risk classes do MICHCLONE ASSOCIATES, INC.'s devices fall under?

Among its 3 most recently registered devices, the classes recorded for MICHCLONE ASSOCIATES, INC.'s devices are Class I and Class II. Each device page shows its own class and authorisation.

Are there FDA recall records for MICHCLONE ASSOCIATES, INC.?

FDA recall records list 3 recalls initiated by MICHCLONE ASSOCIATES, INC., the most recent initiated on 23 Feb 2012. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.

What are the newest devices from MICHCLONE ASSOCIATES, INC. in the registry?

The most recently registered devices listed for MICHCLONE ASSOCIATES, INC. include SICKLE CELL REAGENT SET, ENZYMATIC CHOLESTEROL REAGENT SET and SICKLE-HEME A/S HETEROZYGOUS CONTROL.

Generated automatically from registry data and not verified by a human reviewer.

This is an FDA establishment record. No EUDAMED registration is known for this company.