Gram Positive Autoidentification Plates, Sensititre AP90
FDA 510(k) K972576 · Accumed Intl., Inc.
510(k) numberK972576
Submission
- Device name
- Gram Positive Autoidentification Plates, Sensititre AP90
- Applicant
- Accumed Intl., Inc.
Westlake, OH, US - Received
- July 10, 1997
- Decision date
- January 22, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| 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 |
| K901559 | Modification to Api Uniscept 20GPLQL · Traditional | Analytical Products, Inc. | 09/10/1990SE |
| 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 |
|---|---|---|
| K984489 | Sensititre 18-24 Hour Susceptibility PlatesJWY · Traditional | 02/16/1999SE |
| K983306 | Sensititre 18-24 Hour Susceptibility Plates with GrepafloxacinLTT · Traditional | 12/18/1998SE |
| K983310 | Sensititre 18-24 Hour Susceptibility Plates with SparfloxacinJTT · Traditional | 12/17/1998SE |
| K983309 | Sensititre 19 - 24 Hour Susceptibility Plates with LevofloxacinLTT · Traditional | 12/14/1998SE |
| K983301 | Sensititre 18-24 Hour Susceptibility Plates with TrovafloxacinJWY · Traditional | 11/25/1998SE |
| K982786 | Traccell 2000 Slide Mapping SystemJOY · Traditional | 10/16/1998SE |
| K964689 | Traccell 2000 Slide Mapping SystemJOY · Traditional | 08/18/1997SE |
| K972756 | Modification of Est Culture System II - MycoMDB · Traditional | 08/01/1997SE |
| K965190 | Sensititre Haemophilus/Streptococcus Pneumoniae Mic PlateJWY · Traditional | 03/19/1997SE |
| K960366 | Sensititre 18 Hour Susceptibility PlatesLTT · Traditional | 04/09/1996SE |
Questions and answers
When was Gram Positive Autoidentification Plates, Sensititre AP90 cleared by the FDA?
Gram Positive Autoidentification Plates, Sensititre AP90 (K972576) received a 510(k) decision of Substantially Equivalent on January 22, 1998, 196 days after the submission was received.
What is the product code of K972576?
The FDA product code is LQL – Gram Positive Identification Panel, a Class I (low risk) device regulated under 21 CFR 866.2660.