Phenobarbital Fluorescent Immuno
FDA 510(k) K821408 · American Diagnostic Corp.
510(k) numberK821408
Submission
- Device name
- Phenobarbital Fluorescent Immuno
- Applicant
- American Diagnostic Corp.
Mchenry, IL, US - Received
- May 11, 1982
- Decision date
- May 24, 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 |
| 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 |
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Questions and answers
When was Phenobarbital Fluorescent Immuno cleared by the FDA?
Phenobarbital Fluorescent Immuno (K821408) received a 510(k) decision of Substantially Equivalent on May 24, 1982, 13 days after the submission was received.
What is the product code of K821408?
The FDA product code is LET – Fluorescent Immunoassay, Phenobarbital, a Class II (moderate risk) device regulated under 21 CFR 862.3660.