Myreader 7
FDA 510(k) K853284 · Scientific Sales Intl., Inc.
510(k) numberK853284
Submission
- Device name
- Myreader 7
- Applicant
- Scientific Sales Intl., Inc.
Kalamazoo, MI, US - Received
- August 5, 1985
- Decision date
- October 4, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2300
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJQ
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|---|---|---|---|
| K013371 | UBIT-IR300 Infrared Spectrometry SystemJJQ · Traditional | Otsuka Pharmaceutical Co., Ltd. | 12/21/2001SE |
| K980120 | Digene DML 2000 Microplate LuminometerJJQ · Traditional | Digene Corp. | 02/06/1998SE |
| K973938 | Alpha 4 LS Automated Microtiterplate Processor and ReaderJJQ · Traditional | Sfri, Inc. | 02/04/1998SE |
| K974762 | Stat TracksJJQ · Traditional | Awareness Technology, Inc. | 01/28/1998SE |
| K962113 | Anthos Phacts Version Microplate ReaderJJQ · Traditional | Columbia Bioscience, Inc. | 11/05/1996SE |
| K961183 | Cbi 7520 ReaderJJQ · Traditional | Columbia Bioscience, Inc. | 08/02/1996SE |
| K962166 | Origen AnalyzerJJQ · Traditional | Igen, Inc. | 07/31/1996SE |
| K955077 | Anthos 2010 ReaderJJQ · Traditional | Anthos Labtec, Inc. | 12/04/1995SE |
| K953710 | ELX808 Automated Microplate ReadersJJQ · Traditional | Bio-Tek Instruments, Inc. | 10/25/1995SE |
| K953572 | ELX800UVJJQ · Traditional | Bio-Tek Instruments, Inc. | 10/19/1995SE |
More from Bio-Tek Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K953677 | Lighted Flexguide (Modification)BSR · Traditional | 08/25/1995SE |
| K940799 | FlexguideBSR · Traditional | 08/18/1994SE |
| K860996 | Sanassay Ic TestDAK · Traditional | 03/30/1987SE |
| K862087 | Santest 1APLKL · Traditional | 12/03/1986SE |
| K861336 | Iap Plate TestLKL · Traditional | 04/25/1986SE |
| K853285 | Mywasher 5LIB · Traditional | 10/04/1985SE |
| K853380 | SPR 2 AutodiluterJTC · Traditional | 09/12/1985SE |
| K853379 | Plate IncubatorJTQ · Traditional | 09/03/1985SE |
| K833022 | Air Uterine Displacer-Aud 120CCX · Traditional | 10/14/1983SE |
| K802416 | Salem/Resce Intubation GuideBSR · Traditional | 10/23/1980SE |
Questions and answers
When was Myreader 7 cleared by the FDA?
Myreader 7 (K853284) received a 510(k) decision of Substantially Equivalent on October 4, 1985, 60 days after the submission was received.
What is the product code of K853284?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.