Emit-St Urine Cocaine Metabolite Assay
FDA 510(k) K820773 · Syva Co.
510(k) numberK820773
Submission
- Device name
- Emit-St Urine Cocaine Metabolite Assay
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- March 23, 1982
- Decision date
- April 8, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DID – Bacillus Subtilis Microbiology Assay, Tobramycin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3900
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DID
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K802038 | Phenytoin Reagent Test KitDID · Traditional | Beckman Instruments, Inc. | 10/23/1980SE |
| K780950 | Bio-Monitor TobramycinDID · Traditional | Monitor Science Corp. | 08/14/1978SE |
| K780182 | Tobramycin 125I Ria KitDID · Traditional | New England Nuclear | 02/13/1978SE |
| K780048 | Aminoglycoside Test SystemDID · Traditional | Nichols Institute Diagnostics | 01/20/1978SE |
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| K993981 | Syva Emit II Plus Propoxyphene Assay, Models 9G029UL/9G129ULJXN · Traditional | 02/01/2000SE |
| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | 02/01/2000SE |
| 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-St Urine Cocaine Metabolite Assay cleared by the FDA?
Emit-St Urine Cocaine Metabolite Assay (K820773) received a 510(k) decision of Substantially Equivalent on April 8, 1982, 16 days after the submission was received.
What is the product code of K820773?
The FDA product code is DID – Bacillus Subtilis Microbiology Assay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.