Analyzer, Impact 100
FDA 510(k) K790073 · Gilford Instrument Laboratories, Inc.
510(k) numberK790073
Submission
- Device name
- Analyzer, Impact 100
- Applicant
- Gilford Instrument Laboratories, Inc.
Mchenry, IL, US - Received
- January 11, 1979
- Decision date
- February 22, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJI – Analyzer, Enzyme, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2500
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K972024 | Coda Automated Eia AnalyzerJJI · Traditional | Bio-Rad | 07/30/1997SE |
| K944731 | Abbott Imx 2 AnalyzerJJI · Traditional | Abbott Laboratories | 12/19/1994SE |
| K931970 | Abbott IMX2 AnalyerJJI · Traditional | Abbott Laboratories | 06/16/1993SE |
| K930898 | Radias Automated Immunoassay SystemJJI · Traditional | Bio-Rad | 04/21/1993SE |
| K780972 | Quickrate Reaction Rate AnalyzerJJI · Traditional | Olympus Corp. | 08/14/1978SE |
| K771591 | Ministat-S Chemistry AnalyzerJJI · Traditional | Biokinetix Corp. | 09/20/1977SE |
| K770401 | Ldh/Nadh,Ldh/Nadh, Nad & Nad DiaphoraseJJI · Traditional | Bd Becton Dickinson Vacutainer Systems Preanalytic | 04/26/1977SE |
More from Bd Becton Dickinson Vacutainer Systems Preanalytic
| 510(k) | Device | Decision |
|---|---|---|
| K823233 | Sba 300 Clinical Chemistry AnalyzerJJC · Traditional | 11/29/1982SE |
| K821583 | Ames/Gilford Optimate Clin. Chem & TherJJF · Traditional | 06/24/1982SE |
| K802609 | Chemistry Analyzer Impact 400JJE · Traditional | 11/26/1980SE |
| K801889 | Model 203S Clinical Chemistry AnalyzerJJE · Traditional | 09/26/1980SE |
| K800085 | System 203 Chemistry AnalyzerJJE · Traditional | 02/13/1980SE |
| K792361 | System 103 Chemistry AnalyzerJJE · Traditional | 12/27/1979SE |
| K792087 | Microflame PhotometerJJO · Traditional | 11/13/1979SE |
| K791968 | Eia (Elisa) ReaderJJQ · Traditional | 10/17/1979SE |
| K790072 | Analyzer, Impact 200JJE · Traditional | 02/22/1979SE |
| K781269 | Elisa SystmeJJQ · Traditional | 12/04/1978SE |
Questions and answers
When was Analyzer, Impact 100 cleared by the FDA?
Analyzer, Impact 100 (K790073) received a 510(k) decision of Substantially Equivalent on February 22, 1979, 42 days after the submission was received.
What is the product code of K790073?
The FDA product code is JJI – Analyzer, Enzyme, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2500.