Modification to Api Uniscept 20GP
FDA 510(k) K901559 · Analytical Products, Inc.
510(k) numberK901559
Submission
- Device name
- Modification to Api Uniscept 20GP
- Applicant
- Analytical Products, Inc.
Plainview, NY, US - Received
- April 3, 1990
- Decision date
- September 10, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LQL – Gram Positive Identification Panel
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code LQL
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972576 | Gram Positive Autoidentification Plates, Sensititre AP90LQL · Traditional | Accumed Intl., Inc. | 01/22/1998SE |
| K961968 | Bblcrystal Gram-Positive Id SystemLQL · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 02/04/1997SE |
| K961730 | Rapid Gram-Positive Id SystemLQL · Traditional | Becton Dickinson Microbiology Systems | 02/04/1997SE |
| K952095 | Vitek Gram Positive Identification Card (Gpi)LQL · Traditional | Biomerieux Vitek, Inc. | 03/12/1996SE |
| K925916 | Vitek Rapid Call-Gram Positive Identification CardLQL · Traditional | Biomerieux Vitek, Inc. | 03/23/1993SE |
| K910304 | Rapid Coryne Syst/Identif of Coryneform BacteriaLQL · Traditional | Vitek Systems, Inc. | 07/26/1991SE |
| K910537 | Visi-StrepLQL · Traditional | Kev Connecticut Diagnostics, Inc. | 04/12/1991SE |
| K891004 | Rapidec StaphLQL · Traditional | Dms Products, Inc. | 11/09/1989SE |
| K874606 | Cathra Gram Positive ScreenLQL · Traditional | Mct Medical, Inc. | 05/06/1988SE |
| K863038 | Gram Positive Fluorescent Identification PanelLQL · Traditional | American Micro Scan | 09/30/1986SE |
More from American Micro Scan
| 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 |
| 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 |
| K865062 | Aladin (TM)LRG · Traditional | 03/25/1987SE |
Questions and answers
When was Modification to Api Uniscept 20GP cleared by the FDA?
Modification to Api Uniscept 20GP (K901559) received a 510(k) decision of Substantially Equivalent on September 10, 1990, 160 days after the submission was received.
What is the product code of K901559?
The FDA product code is LQL – Gram Positive Identification Panel, a Class I (low risk) device regulated under 21 CFR 866.2660.