Mastercap Am 5.0/MASTERCAP RM 5.0
FDA 510(k) K970420 · Pharmacia, Inc.
510(k) numberK970420
Submission
- Device name
- Mastercap Am 5.0/MASTERCAP RM 5.0
- Applicant
- Pharmacia, Inc.
Westervillle, OH, US - Received
- February 3, 1997
- Decision date
- June 30, 1997
- 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
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 |
| 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 |
| K951753 | Medtec Autoblot 2000JQW · Traditional | Medtec, Inc. | 10/17/1995SE |
More from Medtec, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K974350 | Allergan Immuno Cap M4, M8, K70DHB · Traditional | 02/09/1998SE |
| K972364 | Unicap PhadiatopDHB · Traditional | 09/04/1997SE |
| K972068 | Unicap Specific Ige Feia Assay, Latex Allergen Immunocap K82DHB · Traditional | 07/03/1997SE |
| K964152 | Unicap Total Ige Assay/Pharmacia Total Ige Controls LMHDGC · Traditional | 04/23/1997SE |
| K962274 | Unicap 100DHB · Traditional | 09/12/1996SE |
| K941993 | Pharmacia Cap System Phadiatop FeiaDHB · Traditional | 01/30/1996SE |
| K954337 | Genotropin MixerFMF · Traditional | 11/13/1995SE |
| K951025 | Piston SyringeFMF · Traditional | 10/19/1995SE |
| K952025 | RobocapJQW · Traditional | 07/26/1995SE |
| K911903 | Allergans Pharmacia Cap Sys.Rast Ria/FeiaDHB · Traditional | 08/12/1991SE |
Questions and answers
When was Mastercap Am 5.0/MASTERCAP RM 5.0 cleared by the FDA?
Mastercap Am 5.0/MASTERCAP RM 5.0 (K970420) received a 510(k) decision of Substantially Equivalent on June 30, 1997, 147 days after the submission was received.
What is the product code of K970420?
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.