Modified Opus Phenobarbital Test System
FDA 510(k) K901537 · Pb Diagnostic Systems, Inc.
510(k) numberK901537
Submission
- Device name
- Modified Opus Phenobarbital Test System
- Applicant
- Pb Diagnostic Systems, Inc.
Westwood, MA, US - Received
- April 2, 1990
- Decision date
- June 12, 1990
- 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 |
|---|---|---|---|
| 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 |
| K820188 | Phenobarbital AssayLET · Traditional | Syva Co. | 02/05/1982SE |
| 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 |
|---|---|---|
| K940507 | Opus FT4 Test SystemCEC · Traditional | 07/28/1994SE |
| K934762 | Opus Procainamide Test SystemLAR · Traditional | 07/20/1994SE |
| K933389 | Opus Cmv-GLFZ · Traditional | 06/28/1994SE |
| K934137 | Opus(R) Serology Controls, ModificationMJX · Traditional | 03/07/1994SE |
| K935229 | Opus DigitoxinDPG · Traditional | 12/22/1993SE |
| K934705 | Opus NapaLAN · Traditional | 11/22/1993SE |
| K933675 | Opus Total CKCGS · Traditional | 09/08/1993SE |
| K933066 | Opus EstradiolCHP · Traditional | 09/08/1993SE |
| K932279 | Opus(R) Total B-Hcg Test SystemJHI · Traditional | 07/08/1993SE |
| K926131 | Opus Magnum AnalyzerKHO · Traditional | 06/07/1993SE |
Questions and answers
When was Modified Opus Phenobarbital Test System cleared by the FDA?
Modified Opus Phenobarbital Test System (K901537) received a 510(k) decision of Substantially Equivalent on June 12, 1990, 71 days after the submission was received.
What is the product code of K901537?
The FDA product code is LET – Fluorescent Immunoassay, Phenobarbital, a Class II (moderate risk) device regulated under 21 CFR 862.3660.