Acs Therapeutic Drug Monit Contols, Level I,Ii,Iii
FDA 510(k) K913677 · Analytical Control Systems, Inc.
510(k) numberK913677
Submission
- Device name
- Acs Therapeutic Drug Monit Contols, Level I,Ii,Iii
- Applicant
- Analytical Control Systems, Inc.
Indianapolis, IN, US - Received
- August 19, 1991
- Decision date
- September 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- LAS – Drug Specific Control Materials
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.3280
- Specialty
- Clinical Toxicology
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|---|---|---|---|
| K080459 | Chromesytems Toxicology Calibrators and ControlsLAS · Abbreviated | Chromsystems Instruments & Chemicals GmbH | 11/17/2009SE |
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| K062942 | Quantimetrix Nicosure Cotinine Urine ControlLAS · Traditional | Quantimetrix Corp. | 10/30/2006SE |
| K051074 | Mas Immunosuppressant ControlsLAS · Traditional | Microgenics Corp. | 06/06/2005SE |
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| K030616 | Cedia Cyclosporine Plus High Range Controls 4 and 5LAS · Traditional | Microgenics Corp. | 03/31/2003SE |
| K992151 | Reference Material for DELTA-9-THC-COOH in Human UrineLAS · Traditional | Consolidated Technologies, Inc. | 07/14/1999SE |
| K970517 | Innofluor Topiramate Control SetLAS · Traditional | Oxis Intl., Inc. | 05/12/1997SE |
| K971210 | Synchron Systems 10 Ng/Ml & 40 Ng/Ml THC Urine ControlsLAS · Traditional | Beckman Instruments, Inc. | 04/17/1997SE |
More from Beckman Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K961892 | Specktin-La Test SetGFO · Traditional | 03/07/1997SE |
| K941115 | Acs Cardio-Trol ControlJJY · Traditional | 07/20/1994SE |
| K940272 | Acs Normal Angiotensin Converting Enzyme ControlJJX · Traditional | 04/20/1994SE |
| 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 Monit Contols, Level I,Ii,Iii cleared by the FDA?
Acs Therapeutic Drug Monit Contols, Level I,Ii,Iii (K913677) received a 510(k) decision of Substantially Equivalent on September 25, 1991, 37 days after the submission was received.
What is the product code of K913677?
The FDA product code is LAS – Drug Specific Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.