Vitros Chemistry Products TDM Performance Verifiers I, II, and III
FDA 510(k) K982649 · Ortho-Clinical Diagnostics, Inc.
510(k) numberK982649
Submission
- Device name
- Vitros Chemistry Products TDM Performance Verifiers I, II, and III
- Applicant
- Ortho-Clinical Diagnostics, Inc.
Rochester, NY, US - Received
- July 30, 1998
- Decision date
- August 12, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
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| 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 Vitros Chemistry Products TDM Performance Verifiers I, II, and III cleared by the FDA?
Vitros Chemistry Products TDM Performance Verifiers I, II, and III (K982649) received a 510(k) decision of Substantially Equivalent on August 12, 1998, 13 days after the submission was received.
What is the product code of K982649?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.