Data / Medical devices / United States / Analytical Control Systems
Analytical Control Systems: FDA-registered device maker in Fishers, IN, United States, 4 510(k) clearances
Analytical Control Systems is registered with the FDA (registration 1825740) in Fishers, IN, United States. It lists 3 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 20, 1994. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1825740
- Address
- 9058 Technology Drive, Fishers, IN, United States, 46038
- Owner or operator
- ANALYTICAL CONTROL SYSTEMS (1825740)
- Roles
- Manufacturer
- First device listed
- December 24, 2013
- Registered through
- 2026
- Brand names listed
- Angiotensin Converting Enzyme Calibrator, HC-102 AFSC, HC-102N NAFSC, HC-103 AF, HC-104 AS, HC-105 AC, HC-106 F Normal, HC-106EL F Abnormal and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calibrator, Primary | JIS | 2 | Manufacturer | accessdata.fda.gov |
| Single (Specified) Analyte Controls (Assayed And Unassayed) | JJX | 1 | Manufacturer | accessdata.fda.gov |
| Whole Blood Hemoglobin Determination | KHG | 2 | 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 20, 1994 | K940272 | ACS NORMAL ANGIOTENSIN CONVERTING ENZYME CONTROL | JJX | Substantially Equivalent | Analytical Control Systems, Inc. | accessdata.fda.gov |
| June 7, 1993 | K930477 | ACS ANGIOTENSIN CONVERTING ENZYME (ACE) CALIBRATOR | JIS | Substantially Equivalent | Analytical Control Systems, Inc. | accessdata.fda.gov |
| November 12, 1980 | K802569 | ABNORMAL HEMOGLOBIN CONTROL | KHG | Substantially Equivalent | Marilyn L. Amick | accessdata.fda.gov |
| November 12, 1980 | K802568 | HEMOGLOBIN CONTROL | KHG | Substantially Equivalent | Marilyn L. Amick | accessdata.fda.gov |
Compare with other makers
- All makers of Whole Blood Hemoglobin Determination
- All makers of Calibrator, Primary
- All makers of Single (Specified) Analyte Controls (Assayed And Unassayed)
Updated April 20, 1994. 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.