Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level C2, Liquichek Urine Toxicology Con
FDA 510(k) K981590 · Bio-Rad
510(k) numberK981590
Submission
- Device name
- Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level C2, Liquichek Urine Toxicology Con
- Applicant
- Bio-Rad
Irvine, CA, US - Received
- May 4, 1998
- Decision date
- June 10, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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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| 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 Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level C2, Liquichek Urine Toxicology Con cleared by the FDA?
Liquichek Urine Toxicology Control Level C1, Liquichek Urine Toxicology Control Level C2, Liquichek Urine Toxicology Con (K981590) received a 510(k) decision of Substantially Equivalent on June 10, 1998, 37 days after the submission was received.
What is the product code of K981590?
The FDA product code is DIF – Drug Mixture Control Materials, a Class I (low risk) device regulated under 21 CFR 862.3280.