Emit(R) II 9 Cannabinoid Negative Calibra/Controls
FDA 510(k) K904569 · Syva Co.
510(k) numberK904569
Submission
- Device name
- Emit(R) II 9 Cannabinoid Negative Calibra/Controls
- Applicant
- Syva Co.
Palo Alto, CA, US - Received
- October 9, 1990
- Decision date
- December 26, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DLJ – Calibrators, Drug Specific
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3200
- Specialty
- Clinical Toxicology
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| K993981 | Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129ULJXN · Traditional | 02/01/2000SE |
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| K993988 | Syva Emit II Plus Cocaine Metabolite Assay, Model 9H029ULDIO · Traditional | 01/27/2000SE |
| K993987 | Syva Emit II Plus Barbiturate Assay, Model 9D029UL/9D129ULKLT · Traditional | 01/27/2000SE |
| K993986 | Syva Emit II Plus Methaqualone Assay, Model 9Q029UL/9Q129ULKXS · Traditional | 01/27/2000SE |
Questions and answers
When was Emit(R) II 9 Cannabinoid Negative Calibra/Controls cleared by the FDA?
Emit(R) II 9 Cannabinoid Negative Calibra/Controls (K904569) received a 510(k) decision of Substantially Equivalent on December 26, 1990, 78 days after the submission was received.
What is the product code of K904569?
The FDA product code is DLJ – Calibrators, Drug Specific, a Class II (moderate risk) device regulated under 21 CFR 862.3200.