Ames Tda Gentamicin Test
FDA 510(k) K810942 · Miles Laboratories, Inc.
510(k) numberK810942
Submission
- Device name
- Ames Tda Gentamicin Test
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- April 7, 1981
- Decision date
- April 17, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LCQ – Fluorescent Immunoassay Gentamicin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3450
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LCQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972609 | Variant Express Glycohemoglobin ProgramLCQ · Traditional | Bio-Rad | 08/06/1997SE |
| K955569 | Innofluor Gentamicin Assay SystemLCQ · Traditional | Oxis Intl., Inc. | 02/09/1996SE |
| K945523 | Cobas(R)-Fp Reagents for Gentamicin and Cobas(R)-Fp Gentamicin CalibratorsLCQ · Traditional | Roche Diagnostic Systems, Inc. | 03/09/1995SE |
| K943550 | Gentamicin Fpia Reagent Set and CalibratorsLCQ · Traditional | Sigma Diagnostics, Inc. | 11/17/1994SE |
| K905721 | Opus GentamicinLCQ · Traditional | Pb Diagnostic Systems, Inc. | 02/21/1991SE |
| K904226 | 'Tdxflx AnalyzerLCQ · Traditional | Abbott Laboratories | 10/29/1990SE |
| K894523 | FPR Gentamicin KitLCQ · Traditional | Colony Laboratories, Inc. | 09/28/1989SE |
| K852158 | Bioprobe Fluor Gentamicin in Serum or PlasmaLCQ · Traditional | Bioprobe Intl., Inc. | 06/25/1985SE |
| K852013 | Gentamicin Kit(Fpia)LCQ · Traditional | Windsor Laboratories, Inc. | 06/10/1985SE |
| K843827 | Cobas Reagents for Gentamicin & CalibratLCQ · Traditional | Roche Diagnostic Systems, Inc. | 02/01/1985SE |
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| 510(k) | Device | Decision |
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| 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 Gentamicin Test cleared by the FDA?
Ames Tda Gentamicin Test (K810942) received a 510(k) decision of Substantially Equivalent on April 17, 1981, 10 days after the submission was received.
What is the product code of K810942?
The FDA product code is LCQ – Fluorescent Immunoassay Gentamicin, a Class II (moderate risk) device regulated under 21 CFR 862.3450.