HS-100 Headspace Sampling Accessory
FDA 510(k) K831387 · The Perkin-Elmer Corp.
510(k) numberK831387
Submission
- Device name
- HS-100 Headspace Sampling Accessory
- Applicant
- The Perkin-Elmer Corp.
Mchenry, IL, US - Received
- April 28, 1983
- Decision date
- August 24, 1983
- 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 |
| 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 |
| K770639 | Detector, Ir, Model GC-33KZQ · Traditional | Peokin-Elmer Corp. | 06/24/1977SE |
More from Peokin-Elmer Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K935666 | Perkin-Elmer Series 200 Liq Chromatographic PumpKIE · Traditional | 04/26/1994SE |
| K900828 | Perkin-Elmer Aa 3100 Atomic Absorption Spectro.JXR · Traditional | 04/09/1990SE |
| K884864 | Plasma 40 Induct. Coupled Plasma Emmission SpectroJJQ · Traditional | 02/10/1989SE |
| K884886 | Model 250 Liquid Chromotagraphy PumpLDM · Traditional | 02/02/1989SE |
| K872737 | Perkin-Elmer LC235 Diode Array Detector · Traditional | 09/18/1987SE |
| K872464 | Ion Trap Detector (Itd)DOP · Traditional | 08/11/1987SE |
| K871550 | PFI-20 Polarizing FluorimeterKHO · Traditional | 07/01/1987SE |
| K872122 | 8000 Series Gas ChromatographsKZQ · Traditional | 06/17/1987SE |
| K870661 | Lifewatch PlusBZQ · Traditional | 03/09/1987SE |
| K862605 | Modular Mass Spectrometer (M.S.)CCK · Traditional | 08/13/1986SE |
Questions and answers
When was HS-100 Headspace Sampling Accessory cleared by the FDA?
HS-100 Headspace Sampling Accessory (K831387) received a 510(k) decision of Substantially Equivalent on August 24, 1983, 118 days after the submission was received.
What is the product code of K831387?
The FDA product code is KZQ – Chromatography(Gas), Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2250.