Immpulse Coated Tube Phenobarbital Assay Reagents
FDA 510(k) K865000 · Sclavo, Inc.
510(k) numberK865000
Submission
- Device name
- Immpulse Coated Tube Phenobarbital Assay Reagents
- Applicant
- Sclavo, Inc.
Sunnyvale, CA, US - Received
- December 22, 1986
- Decision date
- February 6, 1987
- 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 |
| 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 |
|---|---|---|
| K914789 | Elisa CMV IgmLKQ · Traditional | 03/04/1992SE |
| K914852 | Elisa Toxo IgmLGD · Traditional | 01/23/1992SE |
| K914420 | Elisa Rubella IgmLFX · Traditional | 12/27/1991SE |
| K895943 | Normal and Abnormal Control SeraJJY · Traditional | 12/27/1989SE |
| K895822 | Total Bilirubin L.F.CIG · Traditional | 11/14/1989SE |
| K895847 | Creatinine 340 (Enzymatic)CGX · Traditional | 10/30/1989SE |
| K880199 | Cholinesterase - Acetythiocholine SubstrateDIH · Traditional | 01/27/1989SE |
| K880049 | Cholinesterase - Butyrythiocholine SubstrateDIH · Traditional | 01/27/1989SE |
| K873496 | Atypical CholinesteraseDIH · Traditional | 01/27/1989SE |
| K884035 | Saitron 430 Random Access Chemistry AnalyzerJJE · Traditional | 12/29/1988SE |
Questions and answers
When was Immpulse Coated Tube Phenobarbital Assay Reagents cleared by the FDA?
Immpulse Coated Tube Phenobarbital Assay Reagents (K865000) received a 510(k) decision of Substantially Equivalent on February 6, 1987, 46 days after the submission was received.
What is the product code of K865000?
The FDA product code is LET – Fluorescent Immunoassay, Phenobarbital, a Class II (moderate risk) device regulated under 21 CFR 862.3660.