Spectrophotometer Cary 219
FDA 510(k) K772022 · Varian Assoc., Inc.
510(k) numberK772022
Submission
- Device name
- Spectrophotometer Cary 219
- Applicant
- Varian Assoc., Inc.
Mchenry, IL, US - Received
- October 26, 1977
- Decision date
- November 11, 1977
- 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
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|---|---|---|---|
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| 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 |
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| K992753 | Cadplan Plus: 3D Treatment Planning SystemMUJ · Special | 09/03/1999SE |
| K990085 | Millennium MLC -120IYE · Special | 02/08/1999SE |
| K980601 | Varisource Wright Vaginal Cuff Applicator for Varian Varisource Remote High Dose Rate…JAQ · Traditional | 10/21/1998SE |
| K955844 | Applicators for Varian Varisource Remote High Dose Rate AfterloaderJAQ · Traditional | 07/26/1996SE |
| K955774 | Varis PortalvisionIYE · Traditional | 03/15/1996SE |
| K954467 | Cadplan BTJAQ · Traditional | 03/15/1996SE |
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Questions and answers
When was Spectrophotometer Cary 219 cleared by the FDA?
Spectrophotometer Cary 219 (K772022) received a 510(k) decision of Substantially Equivalent on November 11, 1977, 16 days after the submission was received.
What is the product code of K772022?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.