Series 10 Liquid Chromotograph

FDA 510(k) K821727 · The Perkin-Elmer Corp.

Substantially Equivalent

510(k) numberK821727

Submission

Device name
Series 10 Liquid Chromotograph
Applicant
The Perkin-Elmer Corp.
Mchenry, IL, US
Received
June 11, 1982
Decision date
June 22, 1982
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LDM – Instrumentation, High Pressure Liquid Chromatography
Device class
Class I (low risk)
Regulation
21 CFR 862.2260
Specialty
Clinical Chemistry

Other 510(k)s with product code LDM

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K960392CDMLDM · Traditional Bio-Rad07/08/1996SE
K961557Alliance 2690 Separations ModuleLDM · Traditional Waters Corporation07/05/1996SE
K942451Bio-Rad Clinical Data Management SystemLDM · Traditional Bio-Rad11/10/1994SE
K922388Waters(Tm) LC Module I for Clinical UseLDM · Traditional Millipore Corp.09/11/1992SE
K920136Waters 717 AutosamplerLDM · Traditional Millipore Corp.02/19/1992SE
K903647Module 486 Variable Wavelength Tunable Uv/Vis DeteLDM · Traditional Millipore Corp.09/11/1990SE
K884886Model 250 Liquid Chromotagraphy PumpLDM · Traditional The Perkin-Elmer Corp.02/02/1989SE
K872582High Pressure Liquid Chromatography SystemLDM · Traditional Millipore Corp.07/16/1987SE
K870949Waters 650 Advanced Protein Purification SystemLDM · Traditional Millipore Corp.04/22/1987SE
K862178Isopure LC SystemLDM · Traditional The Perkin-Elmer Corp.07/14/1986SE

More from The Perkin-Elmer Corp.

510(k)DeviceDecision
K935666Perkin-Elmer Series 200 Liq Chromatographic PumpKIE · Traditional 04/26/1994SE
K900828Perkin-Elmer Aa 3100 Atomic Absorption Spectro.JXR · Traditional 04/09/1990SE
K884864Plasma 40 Induct. Coupled Plasma Emmission SpectroJJQ · Traditional 02/10/1989SE
K884886Model 250 Liquid Chromotagraphy PumpLDM · Traditional 02/02/1989SE
K872737Perkin-Elmer LC235 Diode Array Detector · Traditional 09/18/1987SE
K872464Ion Trap Detector (Itd)DOP · Traditional 08/11/1987SE
K871550PFI-20 Polarizing FluorimeterKHO · Traditional 07/01/1987SE
K8721228000 Series Gas ChromatographsKZQ · Traditional 06/17/1987SE
K870661Lifewatch PlusBZQ · Traditional 03/09/1987SE
K862605Modular Mass Spectrometer (M.S.)CCK · Traditional 08/13/1986SE

Questions and answers

When was Series 10 Liquid Chromotograph cleared by the FDA?

Series 10 Liquid Chromotograph (K821727) received a 510(k) decision of Substantially Equivalent on June 22, 1982, 11 days after the submission was received.

What is the product code of K821727?

The FDA product code is LDM – Instrumentation, High Pressure Liquid Chromatography, a Class I (low risk) device regulated under 21 CFR 862.2260.