Detector, Ir, Model GC-33
FDA 510(k) K770639 · Peokin-Elmer Corp.
510(k) numberK770639
Submission
- Device name
- Detector, Ir, Model GC-33
- Applicant
- Peokin-Elmer Corp.
Mchenry, IL, US - Received
- April 4, 1977
- Decision date
- June 24, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KZQ – Chromatography(Gas), Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2250
- Specialty
- Clinical Chemistry
Other 510(k)s with product code KZQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K872122 | 8000 Series Gas ChromatographsKZQ · Traditional | The Perkin-Elmer Corp. | 06/17/1987SE |
| K841891 | Varian 3300 & 3400 Gas ChromatographsKZQ · Traditional | Varian Assoc., Inc. | 07/09/1984SE |
| K832962 | Gas Chromatograph 5890AKZQ · Traditional | Hewlett-Packard Co. | 10/28/1983SE |
| K831387 | HS-100 Headspace Sampling AccessoryKZQ · Traditional | The Perkin-Elmer Corp. | 08/24/1983SE |
| K830147 | Sigma 300 Gas ChromatrographKZQ · Traditional | The Perkin-Elmer Corp. | 02/07/1983SE |
| K820283 | Sigma 2000 Gas ChromatographKZQ · Traditional | The Perkin-Elmer Corp. | 02/23/1982SE |
| K820025 | Trace Analytical Reduction Gas AnalyzKZQ · Traditional | Trace Analytical | 02/15/1982SE |
| K820071 | Model 5790 Gas ChromatographKZQ · Traditional | Hewlett-Packard Co. | 01/28/1982SE |
| K801745 | Vista 44 Gas Chromatography AnalysisKZQ · Traditional | Varian Assoc., Inc. | 08/20/1980SE |
| K791138 | 5880 Series of Gas ChromatographsKZQ · Traditional | Hewlett-Packard Co. | 07/24/1979SE |
More from Hewlett-Packard Co.
| 510(k) | Device | Decision |
|---|---|---|
| K770638 | Detector, UV, Molel GC-55KIE · Traditional | 06/24/1977SE |
Questions and answers
When was Detector, Ir, Model GC-33 cleared by the FDA?
Detector, Ir, Model GC-33 (K770639) received a 510(k) decision of Substantially Equivalent on June 24, 1977, 81 days after the submission was received.
What is the product code of K770639?
The FDA product code is KZQ – Chromatography(Gas), Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2250.