Aminoglycoside Test System
FDA 510(k) K780048 · Nichols Institute Diagnostics
510(k) numberK780048
Submission
- Device name
- Aminoglycoside Test System
- Applicant
- Nichols Institute Diagnostics
Mchenry, IL, US - Received
- January 9, 1978
- Decision date
- January 20, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DID – Bacillus Subtilis Microbiology Assay, Tobramycin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3900
- Specialty
- Clinical Toxicology
Other 510(k)s with product code DID
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K820773 | Emit-St Urine Cocaine Metabolite AssayDID · Traditional | Syva Co. | 04/08/1982SE |
| K802038 | Phenytoin Reagent Test KitDID · Traditional | Beckman Instruments, Inc. | 10/23/1980SE |
| K780950 | Bio-Monitor TobramycinDID · Traditional | Monitor Science Corp. | 08/14/1978SE |
| K780182 | Tobramycin 125I Ria KitDID · Traditional | New England Nuclear | 02/13/1978SE |
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Questions and answers
When was Aminoglycoside Test System cleared by the FDA?
Aminoglycoside Test System (K780048) received a 510(k) decision of Substantially Equivalent on January 20, 1978, 11 days after the submission was received.
What is the product code of K780048?
The FDA product code is DID – Bacillus Subtilis Microbiology Assay, Tobramycin, a Class II (moderate risk) device regulated under 21 CFR 862.3900.