Cardioactive Drugs Control
FDA 510(k) K802672 · Fisher Scientific Co., LLC
510(k) numberK802672
Submission
- Device name
- Cardioactive Drugs Control
- Applicant
- Fisher Scientific Co., LLC
Mchenry, IL, US - Received
- October 27, 1980
- Decision date
- November 24, 1980
- 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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| 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 |
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| 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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| K874054 | Fisher Diagnostics Hematall III Las ReagentGGK · Traditional | 10/20/1987SE |
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Questions and answers
When was Cardioactive Drugs Control cleared by the FDA?
Cardioactive Drugs Control (K802672) received a 510(k) decision of Substantially Equivalent on November 24, 1980, 28 days after the submission was received.
What is the product code of K802672?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.