Titertek Twinreader 78-630-00
FDA 510(k) K844567 · Flow Laboratories, Inc.
510(k) numberK844567
Submission
- Device name
- Titertek Twinreader 78-630-00
- Applicant
- Flow Laboratories, Inc.
Mclean, VA, US - Received
- November 23, 1984
- Decision date
- March 21, 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
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K861897 | Uniskan IIJJQ · Traditional | 07/01/1986SE |
| K862066 | Titertek Microplate Washer S-12JTC · Traditional | 06/05/1986SE |
| K861824 | Gentamicin Sulfate Solution (10MG Gentamicin)JSK · Traditional | 05/20/1986SE |
| K861823 | Gentamicin Sulfate Solution (50MG Gentamicin)JSK · Traditional | 05/20/1986SE |
| K861791 | Penicillin-Streptomycin-FungizoneJSK · Traditional | 05/20/1986SE |
| K860762 | Gamma-Free Horse SerumKIS · Traditional | 03/10/1986SE |
| K860752 | Goat Serum (29-391-54)KIS · Traditional | 03/10/1986SE |
| K850908 | Titertek Microittration Equip. Handiwash 110 12CHAJTC · Traditional | 03/25/1985SE |
| K844419 | Titertek Multiskan MSS/340JJQ · Traditional | 03/21/1985SE |
| K844418 | Titertek Multiskan MCCJJQ · Traditional | 03/21/1985SE |
Questions and answers
When was Titertek Twinreader 78-630-00 cleared by the FDA?
Titertek Twinreader 78-630-00 (K844567) received a 510(k) decision of Substantially Equivalent on March 21, 1985, 118 days after the submission was received.
What is the product code of K844567?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.