Omega Therapeutic Drug Monit. Control S.
FDA 510(k) K810077 · Hyland Therapeutic Div., Travenol Laboratories
510(k) numberK810077
Submission
- Device name
- Omega Therapeutic Drug Monit. Control S.
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
Mchenry, IL, US - Received
- January 13, 1981
- Decision date
- January 28, 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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| K132174 | Multichem WBTDIF · Abbreviated | Techno-Path Manufacturing , Ltd. | 09/20/2013SE |
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| 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 |
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| K791113 | Low Ionic Strength Solution (Liss)KSG · Traditional | 06/28/1979SE |
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Questions and answers
When was Omega Therapeutic Drug Monit. Control S. cleared by the FDA?
Omega Therapeutic Drug Monit. Control S. (K810077) received a 510(k) decision of Substantially Equivalent on January 28, 1981, 15 days after the submission was received.
What is the product code of K810077?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.