Pasco Gram Negative Identification System
FDA 510(k) K851528 · Pasco Laboratories, Inc.
510(k) numberK851528
Submission
- Device name
- Pasco Gram Negative Identification System
- Applicant
- Pasco Laboratories, Inc.
Wheat Ridge, CO, US - Received
- April 18, 1985
- Decision date
- July 15, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LQM – Gram Negative Identification Panel
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2660
- Specialty
- Microbiology
Other 510(k)s with product code LQM
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K923313 | Roche Oxi/Ferm IILQM · Traditional | Roche Diagnostic Systems, Inc. | 04/05/1993SE |
| K925915 | Vitek Rapid Call-Gram Negativ Ident CardLQM · Traditional | Biomerieux Vitek, Inc. | 03/23/1993SE |
| K912897 | Sceptor Identification SystemLQM · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 10/28/1991SE |
| K911429 | Vitek Gram Negative Identification Card, ModifiedLQM · Traditional | Vitek Systems, Inc. | 06/24/1991SE |
| K890057 | Sensititre Auto Id Plate AP80LQM · Traditional | Radiometer America, Inc. | 06/09/1989SE |
| K862642 | Gram Negative Fluorescent Identification PanelLQM · Traditional | American Micro Scan | 09/11/1986SE |
More from American Micro Scan
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|---|---|---|
| K042331 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 10/07/2004SE |
| K041776 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 08/03/2004SE |
| K041214 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 06/07/2004SE |
| K033119 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 11/18/2003SE |
| K031727 | Pasco Mic and Mic/Id Panels, GemifloxacinJWY · Traditional | 07/30/2003SE |
| K031205 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 06/13/2003SE |
| K031103 | Pasco Mic and Mic/Id Panels (Ertapenem)JWY · Traditional | 06/12/2003SE |
| K030933 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 05/01/2003SE |
| K030620 | Pasco Mic and Mic/Id PanelsLTT · Traditional | 04/14/2003SE |
| K020331 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 03/20/2002SE |
Questions and answers
When was Pasco Gram Negative Identification System cleared by the FDA?
Pasco Gram Negative Identification System (K851528) received a 510(k) decision of Substantially Equivalent on July 15, 1985, 88 days after the submission was received.
What is the product code of K851528?
The FDA product code is LQM – Gram Negative Identification Panel, a Class I (low risk) device regulated under 21 CFR 866.2660.