Series II Liquid Chromatograph

FDA 510(k) K761219 · The Perkin-Elmer Corp.

Substantially Equivalent

510(k) numberK761219

Submission

Device name
Series II Liquid Chromatograph
Applicant
The Perkin-Elmer Corp.
Mchenry, IL, US
Received
December 7, 1976
Decision date
February 1, 1977
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
KIE – Apparatus, 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 KIE

510(k)DeviceApplicantDecision
K964588Waters 515 HPLC Pump (515)KIE · Traditional Waters Corporation11/29/1996SE
K935666Perkin-Elmer Series 200 Liq Chromatographic PumpKIE · Traditional The Perkin-Elmer Corp.04/26/1994SE
K924347Waters(Tm) 996 PdaKIE · Traditional Millipore Corp.12/11/1992SE
K914841Chromatography Clinical Use 75JQRKIE · Traditional Millipore Corp.12/10/1991SE
K911299Equipment/Material Decontaminating KitKIE · Traditional Rohm and Haas Co.04/08/1991SE
K862506The Waters Model 990 Photodiode Array DetectorKIE · Traditional Millipore Corp.07/29/1986SE
K844947Emit Ancillary ReagentsKIE · Traditional Syva Co.06/28/1985SE
K844949Syva Sample SealKIE · Traditional Syva Co.02/15/1985SE
K800556Differential Refractive Index DetectorKIE · Traditional Hewlett-Packard Co.03/25/1980SE
K800516Dupont Instruments Model 870 Liq. Chrom.KIE · Traditional E.I. Dupont DE Nemours & Co., Inc.03/19/1980SE

More from E.I. Dupont DE Nemours & Co., Inc.

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 II Liquid Chromatograph cleared by the FDA?

Series II Liquid Chromatograph (K761219) received a 510(k) decision of Substantially Equivalent on February 1, 1977, 56 days after the submission was received.

What is the product code of K761219?

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