Emit Nortriptyline Assay
FDA 510(k) K870823 · Syva Co.
510(k) numberK870823
Submission
- Device name
- Emit Nortriptyline Assay
- Applicant
- Syva Co.
Palo Alto, CA, US - Received
- March 3, 1987
- Decision date
- March 20, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LFG – Radioimmunoassay, Tricyclic Antidepressant Drugs
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3910
- Specialty
- Clinical Toxicology
Intended to measure any of the tricyclic antidepressant drugs in serum or urine.
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| K861155 | Emit Desipramine AssayLFG · Traditional | Syva Co. | 05/02/1986SE |
| K853113 | TD Tricyclic AntidepressantsLFG · Traditional | Abbott Laboratories | 08/12/1985SE |
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| K993980 | Syva Emit II Plus Ethyl Alcohol Assay, Models 9K309UL/9K409ULDML · Traditional | 02/01/2000SE |
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| K993986 | Syva Emit II Plus Methaqualone Assay, Model 9Q029UL/9Q129ULKXS · Traditional | 01/27/2000SE |
Questions and answers
When was Emit Nortriptyline Assay cleared by the FDA?
Emit Nortriptyline Assay (K870823) received a 510(k) decision of Substantially Equivalent on March 20, 1987, 17 days after the submission was received.
What is the product code of K870823?
The FDA product code is LFG – Radioimmunoassay, Tricyclic Antidepressant Drugs, a Class II (moderate risk) device regulated under 21 CFR 862.3910.