Liquid Chromatographic Detector LC-95
FDA 510(k) K840977 · The Perkin-Elmer Corp.
510(k) numberK840977
Submission
- Device name
- Liquid Chromatographic Detector LC-95
- Applicant
- The Perkin-Elmer Corp.
Mchenry, IL, US - Received
- March 6, 1984
- Decision date
- April 19, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KZR – Chromatography (Liquid, Gel), Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2260
- Specialty
- Clinical Chemistry
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| K905538 | Columns Liquid Chromatography DPMKZR · Traditional | Millpore Corp. | 01/25/1991SE |
| K861392 | Syva Solid Phase Columns System IIKZR · Traditional | Syva Co. | 06/13/1986SE |
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| K851945 | Varian Aasp Automated Sample Prep. SystemKZR · Traditional | Varian Assoc., Inc. | 05/24/1985SE |
| K843568 | Liquid Chromatograph 400KZR · Traditional | The Perkin-Elmer Corp. | 11/20/1984SE |
| K841890 | Varian 2000 Liquid Chromatography AnalyKZR · Traditional | Varian Assoc., Inc. | 06/14/1984SE |
| K832201 | Chrom-PrepKZR · Traditional | Hamilton Co. | 08/16/1983SE |
| K802725 | Vista 54 Liquid Chromatography Anal. SysKZR · Traditional | Varian Assoc., Inc. | 12/11/1980SE |
More from Varian Assoc., Inc.
| 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 Liquid Chromatographic Detector LC-95 cleared by the FDA?
Liquid Chromatographic Detector LC-95 (K840977) received a 510(k) decision of Substantially Equivalent on April 19, 1984, 44 days after the submission was received.
What is the product code of K840977?
The FDA product code is KZR – Chromatography (Liquid, Gel), Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2260.