Emit Tobramycin Control
FDA 510(k) K800151 · Syva Co.
510(k) numberK800151
Submission
- Device name
- Emit Tobramycin Control
- Applicant
- Syva Co.
Mchenry, IL, US - Received
- January 22, 1980
- Decision date
- February 5, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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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 Tobramycin Control cleared by the FDA?
Emit Tobramycin Control (K800151) received a 510(k) decision of Substantially Equivalent on February 5, 1980, 14 days after the submission was received.
What is the product code of K800151?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.