Ac/Ad Linearity Verifiers
FDA 510(k) K982217 · Sc Calibrators & Controls, LLC
510(k) numberK982217
Submission
- Device name
- Ac/Ad Linearity Verifiers
- Applicant
- Sc Calibrators & Controls, LLC
Santa Monica, CA, US - Received
- June 24, 1998
- Decision date
- July 2, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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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| 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 |
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Questions and answers
When was Ac/Ad Linearity Verifiers cleared by the FDA?
Ac/Ad Linearity Verifiers (K982217) received a 510(k) decision of Substantially Equivalent on July 2, 1998, 8 days after the submission was received.
What is the product code of K982217?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.