Ames Tda Phenobarbital Test
FDA 510(k) K842592 · Miles Laboratories, Inc.
510(k) numberK842592
Submission
- Device name
- Ames Tda Phenobarbital Test
- Applicant
- Miles Laboratories, Inc.
Walker, MI, US - Received
- July 3, 1984
- Decision date
- August 17, 1984
- 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 |
| 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 |
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| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
| K874909 | Micro-Bumintest Reagent TabletsJIR · Traditional | 04/28/1988SE |
| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Ames Tda Phenobarbital Test cleared by the FDA?
Ames Tda Phenobarbital Test (K842592) received a 510(k) decision of Substantially Equivalent on August 17, 1984, 45 days after the submission was received.
What is the product code of K842592?
The FDA product code is LET – Fluorescent Immunoassay, Phenobarbital, a Class II (moderate risk) device regulated under 21 CFR 862.3660.