Trimethoprim 5MCG. Sensitivity Discs
FDA 510(k) K801474 · Difco Laboratories, Inc.
510(k) numberK801474
Submission
- Device name
- Trimethoprim 5MCG. Sensitivity Discs
- Applicant
- Difco Laboratories, Inc.
Mchenry, IL, US - Received
- June 24, 1980
- Decision date
- August 13, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JTN – Susceptibility Test Discs, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1620
- Specialty
- Microbiology
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| K954783 | Dryslide CartarrhalisJTO · Traditional | 02/06/1996SE |
| K954784 | Dryside NeisseriaLTS · Traditional | 01/30/1996SE |
| K953129 | Esp Culture System - MycoMDB · Traditional | 12/26/1995SE |
| K950706 | Dryslide CoagulaseJTL · Traditional | 05/16/1995SE |
| K944275 | Dispens-O-Disc Piperacillin 100 Mcg./Tazobactam 10 Mcg.JTN · Traditional | 12/19/1994SE |
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Questions and answers
When was Trimethoprim 5MCG. Sensitivity Discs cleared by the FDA?
Trimethoprim 5MCG. Sensitivity Discs (K801474) received a 510(k) decision of Substantially Equivalent on August 13, 1980, 50 days after the submission was received.
What is the product code of K801474?
The FDA product code is JTN – Susceptibility Test Discs, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1620.