Gleman ACD-2020 Automatic Computing Densitometer
FDA 510(k) K850260 · Gelman Sciences, Inc.
510(k) numberK850260
Submission
- Device name
- Gleman ACD-2020 Automatic Computing Densitometer
- Applicant
- Gelman Sciences, Inc.
Ann Arbor, MI, US - Received
- January 22, 1985
- Decision date
- February 27, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JQT – Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2400
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JQT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K111356 | Asimanager - atJQT · Traditional | Arlington Scientific, Inc. | 11/09/2011SE |
| K944185 | IsoscanJQT · Traditional | Isolab, Inc. | 11/17/1994SE |
| K915332 | Model 795 Fluorometer/DensitometerJQT · Traditional | Ciba Corning Diagnostics Corp. | 02/18/1992SE |
| K885254 | Target ReaderJQT · Traditional | V-Tech, Inc. | 01/27/1989SE |
| K860645 | Electrophoresis Data Center (Edc)JQT · Traditional | Helena Laboratories | 12/17/1986SE |
| K862956 | Icon ReaderJQT · Traditional | Hybritech, Inc. | 08/19/1986SE |
| K853734 | Apollo DensitometerJQT · Traditional | Astral Medical Systems | 09/25/1985SE |
| K851154 | Electrophoresis Apparatus, for Clinical Use 160,18JQT · Traditional | Astral Medical Systems | 05/13/1985SE |
| K850617 | Corning 780 Fluorometer/DensitometerJQT · Traditional | Corning Medical & Scientific | 03/12/1985SE |
| K842313 | Elvi 146 SeroscanJQT · Traditional | Logos Scientific, Inc. | 09/10/1984SE |
More from Logos Scientific, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K946190 | Drug Dispensing SpikeFMF · Traditional | 03/17/1995SE |
| K943127 | Pharmassure Large Volume Transfer FiltersFPB · Traditional | 09/29/1994SE |
| K941589 | Syringe Filter DevicesFMF · Traditional | 09/06/1994SE |
| K941020 | Drug Reconstitution Filter DeviceFMF · Traditional | 08/10/1994SE |
| K942275 | Vial Vent FilterFPB · Traditional | 07/26/1994SE |
| K941032 | UnknownFMF · Traditional | 05/27/1994SE |
| K910821 | Transducer ProtectorFIB · Traditional | 08/12/1991SE |
| K892387 | Modified Gelman Arterial FilterDTM · Traditional | 06/22/1989SE |
| K884176 | Chromatography KitDPA · Traditional | 04/04/1989SE |
| K884178 | Drug Control SetDIF · Traditional | 02/17/1989SE |
Questions and answers
When was Gleman ACD-2020 Automatic Computing Densitometer cleared by the FDA?
Gleman ACD-2020 Automatic Computing Densitometer (K850260) received a 510(k) decision of Substantially Equivalent on February 27, 1985, 36 days after the submission was received.
What is the product code of K850260?
The FDA product code is JQT – Densitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica, a Class I (low risk) device regulated under 21 CFR 862.2400.