Acs Therapeutic Drug Monitoring Control, Level III
FDA 510(k) K911178 · Analytical Control Systems, Inc.
510(k) numberK911178
Submission
- Device name
- Acs Therapeutic Drug Monitoring Control, Level III
- Applicant
- Analytical Control Systems, Inc.
Fishers, IN, US - Received
- March 18, 1991
- Decision date
- May 1, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJX – Single (Specified) Analyte Controls (Assayed And Unassayed)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1660
- Specialty
- Clinical Chemistry
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| K930477 | Acs Angiotensin Converting Enzyme (Ace) CalibratorJIS · Traditional | 06/07/1993SE |
| K926012 | Acs Apct Reagent, ModifiedGFO · Traditional | 04/27/1993SE |
| K925340 | Coagulation Control Containing HemoglobinJPA · Traditional | 03/23/1993SE |
| K925906 | Normal Angiotensin Converting Enzyme ControlJJX · Traditional | 02/18/1993SE |
| K921223 | Acs Freeze-Dried Aptt ReagentGFO · Traditional | 08/18/1992SE |
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Questions and answers
When was Acs Therapeutic Drug Monitoring Control, Level III cleared by the FDA?
Acs Therapeutic Drug Monitoring Control, Level III (K911178) received a 510(k) decision of Substantially Equivalent on May 1, 1991, 44 days after the submission was received.
What is the product code of K911178?
The FDA product code is JJX – Single (Specified) Analyte Controls (Assayed And Unassayed), a Class I (low risk) device regulated under 21 CFR 862.1660.