Api Uniscept Mic 100UL
FDA 510(k) K844159 · Analytical Products, Inc.
510(k) numberK844159
Submission
- Device name
- Api Uniscept Mic 100UL
- Applicant
- Analytical Products, Inc.
Plainview, NY, US - Received
- October 24, 1984
- Decision date
- December 14, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LTW – Susceptibility Test Cards, Antimicrobial
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.1640
- Specialty
- Microbiology
Other 510(k)s with product code LTW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K852613 | Mic-Concept SystemLTW · Traditional | Microtech Medical Systems, Inc. | 09/20/1985SE |
| K853772 | Precept MethicillinLTW · Traditional | Austin Biological Laboratories | 09/16/1985SE |
| K853685 | Precept TM CarbenicillinLTW · Traditional | Austin Biological Laboratories | 09/16/1985SE |
| K853596 | Precept CefoperazoneLTW · Traditional | Austin Biological Laboratories | 09/16/1985SE |
| K853273 | Precept CeftriaxoneLTW · Traditional | Austin Biological Laboratories | 09/16/1985SE |
| K853689 | Precept TM MoxalactamLTW · Traditional | Austin Biological Laboratories | 09/13/1985SE |
| K853688 | Precept TM TobramycinLTW · Traditional | Austin Biological Laboratories | 09/13/1985SE |
| K853687 | Precept Netilmicin 32-13LTW · Traditional | Austin Biological Laboratories | 09/13/1985SE |
| K853686 | Precept TM AmikacinLTW · Traditional | Austin Biological Laboratories | 09/13/1985SE |
| K853684 | Precept KanamycinLTW · Traditional | Austin Biological Laboratories | 09/13/1985SE |
More from Austin Biological Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K924814 | Api 20E/UNISCEPT 20EJSS · Traditional | 03/11/1993SE |
| K923684 | Api Uniscept Mic/Type 2 and 3 and Micro MicJWY · Traditional | 12/03/1992SE |
| K922926 | Api Uniscept Kb/Type 2 and 3JWY · Traditional | 10/13/1992SE |
| K901559 | Modification to Api Uniscept 20GPLQL · Traditional | 09/10/1990SE |
| K901390 | Dmac Indole ReagentJTO · Traditional | 04/16/1990SE |
| K895796 | Api Uniscept KBJWY · Traditional | 11/13/1989SE |
| K884510 | Modification Micro-MicJWY · Traditional | 11/22/1988SE |
| K884509 | Modification Mic/Api Uniscept(R)JWY · Traditional | 11/22/1988SE |
| K880598 | Modifications to Api Uniscept (R) KBJWY · Traditional | 03/23/1988SE |
| K874466 | Api Uniscept(R) Micro-Mic(R) System/Uniscept MicJWY · Traditional | 12/09/1987SE |
Questions and answers
When was Api Uniscept Mic 100UL cleared by the FDA?
Api Uniscept Mic 100UL (K844159) received a 510(k) decision of Substantially Equivalent on December 14, 1984, 51 days after the submission was received.
What is the product code of K844159?
The FDA product code is LTW – Susceptibility Test Cards, Antimicrobial, a Class II (moderate risk) device regulated under 21 CFR 866.1640.