Autoloader
FDA 510(k) K921005 · Innovative Medical Systems, Inc.
510(k) numberK921005
Submission
- Device name
- Autoloader
- Applicant
- Innovative Medical Systems, Inc.
Ivyland, PA, US - Received
- March 3, 1992
- Decision date
- April 29, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
Other 510(k)s with product code JQW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023955 | BD Viper InstrumentJQW · Traditional | Becton, Dickinson & CO | 06/24/2003SE |
| 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 |
More from Tecan U.S., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K973035 | Viola II Dental Camera SystemEIA · Traditional | 09/24/1997SE |
| K951469 | Bazooka SystemFNM · Traditional | 06/28/1995SE |
| K933184 | Positive Airway Pressure SystemBZD · Traditional | 11/28/1994SE |
| K924590 | Microwave Automated Tissue ProcessorIEO · Traditional | 12/29/1992SE |
| K922081 | Labotech Automated Microtiter AnalyzerJJQ · Traditional | 09/02/1992SE |
| K915457 | Phaco 20/20 System IHQC · Traditional | 02/24/1992SE |
| K915456 | Phaco 3000 LinearHQC · Traditional | 02/12/1992SE |
| K883599 | LX-80 Automated Tissue Processor (Plastic)IEO · Traditional | 09/02/1988SE |
| K880745 | LX-100 Slide StainerKPA · Traditional | 04/27/1988SE |
| K853938 | LX 300 Tissue ProcessorIEO · Traditional | 10/10/1985SE |
Questions and answers
When was Autoloader cleared by the FDA?
Autoloader (K921005) received a 510(k) decision of Substantially Equivalent on April 29, 1992, 57 days after the submission was received.
What is the product code of K921005?
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.