Anti-Arrhythmic Control Levels I & II
FDA 510(k) K811809 · Environmental Chemical Specialties
510(k) numberK811809
Submission
- Device name
- Anti-Arrhythmic Control Levels I & II
- Applicant
- Environmental Chemical Specialties
Mchenry, IL, US - Received
- June 25, 1981
- Decision date
- July 10, 1981
- 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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| K153474 | Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine…DIF · Traditional | Biochemical Diagnostics, Inc. | 02/23/2016SE |
| K132688 | Salivabuse Liquid Oral Fluid Control, Salivabuse Liquid Oral Fluid Control, Au/NzDIF · Traditional | Biochemical Diagnostics, Inc. | 12/16/2013SE |
| K132174 | Multichem WBTDIF · Abbreviated | Techno-Path Manufacturing , Ltd. | 09/20/2013SE |
| K121122 | Detectabuse Liquid Control, Detectabuse Stat-Skreen Liquid ControlDIF · Traditional | Biochemical Diagnostic, Inc. | 07/03/2012SE |
| K121143 | Liquichek Whole Blood Immunosuppressant Control Tilevel (1,2 and 3)DIF · Traditional | Bio-Rad Laboratories | 05/18/2012SE |
| K120504 | Liquichek Urine Toxicology Control, S10 & S10 Minipak, Liquichek Urine Toxicology…DIF · Traditional | Bio-Rad Laboratories, Inc. | 03/27/2012SE |
| K103656 | Thermo Scientific Mas R Doa TotalDIF · Traditional | Microgenics Corporation | 03/24/2011SE |
| K093577 | Liquichek Opiate ControlDIF · Traditional | Bio-Rad Laboratories | 03/12/2010SE |
| K080085 | Mas Tox ControlDIF · Traditional | Thermo Fisher Scientific | 04/30/2008SE |
| K080183 | Control Set Dat I, Contrl Set Dat II, Control Set Dat III, Control Set Amphetamine 1000…DIF · Abbreviated | Roche Diagnostics Corp. | 03/25/2008SE |
More from Roche Diagnostics Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K812635 | Anemia ControlJJY · Traditional | 10/02/1981SE |
| K811810 | Uric Acid TestKNK · Traditional | 07/15/1981SE |
| K811811 | TDM Anti-Convulsant Control Levels I-IiDIF · Traditional | 07/10/1981SE |
| K803089 | Gamma-Glutamyl Transpeptidase (GGT)JPZ · Traditional | 01/02/1981SE |
| K792377 | Carcinoembryonic Antigen (Cea) ControlDHX · Traditional | 09/26/1980SE |
| K801854 | Spinal Fluid Control(Human)JJX · Traditional | 09/16/1980SE |
| K801061 | Total Protein TestCEK · Traditional | 07/21/1980SE |
| K792376 | Quantitative Control Urine II (Human)JJW · Traditional | 12/06/1979SE |
| K792375 | Elevated Lipid ControlJJY · Traditional | 12/06/1979SE |
| K792374 | Quantitative Control Urine I (Human)JJW · Traditional | 12/06/1979SE |
Questions and answers
When was Anti-Arrhythmic Control Levels I & II cleared by the FDA?
Anti-Arrhythmic Control Levels I & II (K811809) received a 510(k) decision of Substantially Equivalent on July 10, 1981, 15 days after the submission was received.
What is the product code of K811809?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.