Acs Therapeutic Drug Monitoring Control Set I LE.1
FDA 510(k) K910930 · Analytical Control Systems, Inc.
510(k) numberK910930
Submission
- Device name
- Acs Therapeutic Drug Monitoring Control Set I LE.1
- Applicant
- Analytical Control Systems, Inc.
Indianapolis, IN, US - Received
- March 6, 1991
- Decision date
- May 1, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DIF – Drug Mixture Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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| K940397 | Acs O Dilvent Protein Dilution MatrixJJY · Traditional | 03/11/1994SE |
| 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 |
| K921118 | Acs Apct ReagentGFO · Traditional | 07/28/1992SE |
Questions and answers
When was Acs Therapeutic Drug Monitoring Control Set I LE.1 cleared by the FDA?
Acs Therapeutic Drug Monitoring Control Set I LE.1 (K910930) received a 510(k) decision of Substantially Equivalent on May 1, 1991, 56 days after the submission was received.
What is the product code of K910930?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.