LDC Uviii Fixed Wavelength Ultraviolet

FDA 510(k) K800047 · Laboratory Data Control

Substantially Equivalent

510(k) numberK800047

Submission

Device name
LDC Uviii Fixed Wavelength Ultraviolet
Applicant
Laboratory Data Control
Mchenry, IL, US
Received
January 9, 1980
Decision date
January 21, 1980
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
K800289LDC Spectromonitor IIIKIE · Traditional 02/26/1980SE
K800046LDC Chromatography Accessory Module BKIE · Traditional 02/25/1980SE
K800048LDC Constametric III Hight Press. Sol.KIE · Traditional 01/29/1980SE

Questions and answers

When was LDC Uviii Fixed Wavelength Ultraviolet cleared by the FDA?

LDC Uviii Fixed Wavelength Ultraviolet (K800047) received a 510(k) decision of Substantially Equivalent on January 21, 1980, 12 days after the submission was received.

What is the product code of K800047?

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