Gammacord II Calculator Interface
FDA 510(k) K761063 · Miles Laboratories, Inc.
510(k) numberK761063
Submission
- Device name
- Gammacord II Calculator Interface
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- November 18, 1976
- Decision date
- December 2, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JQP – Calculator/Data Processing Module, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2100
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JQP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K113007 | Bionime Diabetes Management System VI.0JQP · Traditional | Bionime Corporation | 02/27/2012SE |
| K983468 | Fasttake Adapter, Model # P/N 020-072-01JQP · Traditional | Selfcare, Inc. | 12/17/1998SE |
| K964460 | The RoboliteJQP · Traditional | Shai Syg Motion and Innovations, Ltd. | 01/24/1997SE |
| K953652 | Prenval IJQP · Traditional | Base Ten Systems, Inc. | 09/15/1995SE |
| K934111 | MR7000 with Time Manager Software (TMS)JQP · Traditional | Dynatech Laboratories, Inc. | 11/02/1994SE |
| K923316 | Expresso CartridgeJQP · Traditional | Bio-Rad Laboratories, Inc. | 02/23/1993SE |
| K893838 | Modified Model 570 Clinical Chemistry AnalyzerJQP · Traditional | Ciba Corning Diagnostics Corp. | 08/31/1989SE |
| K892060 | Cyberlab High Volume Drug Testing SystemJQP · Traditional | Syva Co. | 08/10/1989SE |
| K885292 | Cobas MFCJQP · Traditional | Roche Diagnostic Systems, Inc. | 03/22/1989SE |
| K881194 | Ria-QuickJQP · Traditional | Quantitative Technologies, Inc. | 06/01/1988SE |
More from Quantitative Technologies, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
| K874909 | Micro-Bumintest Reagent TabletsJIR · Traditional | 04/28/1988SE |
| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Gammacord II Calculator Interface cleared by the FDA?
Gammacord II Calculator Interface (K761063) received a 510(k) decision of Substantially Equivalent on December 2, 1976, 14 days after the submission was received.
What is the product code of K761063?
The FDA product code is JQP – Calculator/Data Processing Module, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2100.