Phenobarbital Assay
FDA 510(k) K820188 · Syva Co.
510(k) numberK820188
Submission
- Device name
- Phenobarbital Assay
- Applicant
- Syva Co.
Walker, MI, US - Received
- January 25, 1982
- Decision date
- February 5, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LET – Fluorescent Immunoassay, Phenobarbital
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3660
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LET
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K901537 | Modified Opus Phenobarbital Test SystemLET · Traditional | Pb Diagnostic Systems, Inc. | 06/12/1990SE |
| K865000 | Immpulse Coated Tube Phenobarbital Assay ReagentsLET · Traditional | Sclavo, Inc. | 02/06/1987SE |
| K842592 | Ames Tda Phenobarbital TestLET · Traditional | Miles Laboratories, Inc. | 08/17/1984SE |
| K830701 | Stratus Phenobarbital Fluorometric EnzLET · Traditional | American Dade | 05/13/1983SE |
| K821408 | Phenobarbital Fluorescent ImmunoLET · Traditional | American Diagnostic Corp. | 05/24/1982SE |
| K810994 | Ames Tda TM Phenobarbital TestLET · Traditional | Miles Laboratories, Inc. | 04/29/1981SE |
| K802255 | Ames Tda Phenobarbital TestLET · Traditional | Miles Laboratories, Inc. | 09/26/1980SE |
More from Miles Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K011878 | Emit (R) Tox Salicylic Assay, Model 7SO19UL, Emit (R) Tox Salicylic Acid Calibrators…DKJ · Traditional | 08/13/2001SE |
| K012257 | Emit II Plus Monoclonal Amphetamine/Methamphetamine Assay Model OSR9C229DKZ · Special | 08/03/2001SE |
| K011947 | Emit 2000 Valproic Acid Assay, Model OSR4G229ULLEG · Special | 07/02/2001SE |
| K011528 | Emit 2000 Phenobarbital Assay, Model OSR4D229DLZ · Special | 06/06/2001SE |
| K011347 | Emit 2000 Phenytoin Assay, Model 0SR4A229DIP · Special | 05/17/2001SE |
| 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 Phenobarbital Assay cleared by the FDA?
Phenobarbital Assay (K820188) received a 510(k) decision of Substantially Equivalent on February 5, 1982, 11 days after the submission was received.
What is the product code of K820188?
The FDA product code is LET – Fluorescent Immunoassay, Phenobarbital, a Class II (moderate risk) device regulated under 21 CFR 862.3660.