Medtec Autoblot 2000
FDA 510(k) K951753 · Medtec, Inc.
510(k) numberK951753
Submission
- Device name
- Medtec Autoblot 2000
- Applicant
- Medtec, Inc.
Washington, DC, US - Received
- April 17, 1995
- Decision date
- October 17, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JQW – Station, Pipetting And Diluting, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2750
- Specialty
- Clinical Chemistry
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| K973335 | Quatro SP Sample Processing Systems (200-499, Inclusive)JQW · Traditional | Zenyx Scientific , Ltd. | 04/30/1998SE |
| K980180 | 2700 Sample ManagerJQW · Traditional | Waters Corporation | 02/12/1998SE |
| K970420 | Mastercap Am 5.0/MASTERCAP RM 5.0JQW · Traditional | Pharmacia, Inc. | 06/30/1997SE |
| K970616 | Mini Sampler ProcessorJQW · Traditional | Cavro Scientific Instruments, Inc. | 04/21/1997SE |
| K962687 | Gio. de Vita E C. S.R.L.(Gdv) Automatic Washing SystemJQW · Traditional | Nichols Institute Diagnostics | 03/28/1997SE |
| K962859 | Mini Sample ProcessorJQW · Traditional | Cavro Scientific Instruments, Inc. | 10/29/1996SE |
| K961896 | Microlab 4000, Microlab 4200JQW · Traditional | Hamilton Co. | 08/16/1996SE |
| K961694 | ImpactJQW · Traditional | Matrix Technologies Corp. | 06/21/1996SE |
| K953345 | GenesisJQW · Traditional | Tecan U.S., Inc. | 11/21/1995SE |
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| K093738 | MRI Patient Positioning DevicesLNH · Traditional | 05/14/2010SE |
| K974703 | Carbon Fiber Breast BoardIYE · Traditional | 03/10/1998SE |
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| K973842 | Carbon Fiber Conformal Couch TopIXQ · Traditional | 12/05/1997SE |
| K962622 | Intra-Oral Thermoplastic ShieldKPY · Traditional | 10/01/1996SE |
| K955236 | Green TEC-2100IWE · Traditional | 05/24/1996SE |
| K954705 | Acrysteel Blocking TrayIYE · Traditional | 01/05/1996SE |
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Questions and answers
When was Medtec Autoblot 2000 cleared by the FDA?
Medtec Autoblot 2000 (K951753) received a 510(k) decision of Substantially Equivalent on October 17, 1995, 183 days after the submission was received.
What is the product code of K951753?
The FDA product code is JQW – Station, Pipetting And Diluting, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2750.