Product code KIE— Clinical Chemistry

FDA has cleared 25 devices under product code KIE between 1977 and 1996, filed by 11 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

• 19961 clearance
• 19941 clearance
• 19921 clearance
• 19912 clearances
• 19861 clearance
• 19852 clearances
• 19806 clearances
• 19794 clearances
• 19783 clearances
• 19774 clearances

• Waters Assoc., Inc.4 clearances
• Laboratory Data Control4 clearances
• Hewlett-Packard Co.4 clearances
• The Perkin-Elmer Corp.3 clearances
• Millipore Corp.3 clearances
• Syva Co.2 clearances
• Waters Corporation1 clearance
• Varian Assoc., Inc.1 clearance
• Rohm and Haas Co.1 clearance
• Peokin-Elmer Corp.1 clearance

• K964588 — WATERS 515 HPLC PUMP (515)Waters Corporation·1996-11-29
• K935666 — PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMPThe Perkin-Elmer Corp.·1994-04-26
• K924347 — WATERS(TM) 996 PDAMillipore Corp.·1992-12-11
• K914841 — CHROMATOGRAPHY CLINICAL USE 75JQRMillipore Corp.·1991-12-10
• K911299 — EQUIPMENT/MATERIAL DECONTAMINATING KITRohm and Haas Co.·1991-04-08
• K862506 — THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTORMillipore Corp.·1986-07-29
• K844947 — EMIT ANCILLARY REAGENTSSyva Co.·1985-06-28
• K844949 — SYVA SAMPLE SEALSyva Co.·1985-02-15
• K800556 — DIFFERENTIAL REFRACTIVE INDEX DETECTORHewlett-Packard Co.·1980-03-25
• K800516 — DUPONT INSTRUMENTS MODEL 870 LIQ. CHROM.E.I. Dupont DE Nemours & Co., Inc.·1980-03-19
• K800289 — LDC SPECTROMONITOR IIILaboratory Data Control·1980-02-26
• K800046 — LDC CHROMATOGRAPHY ACCESSORY MODULE BLaboratory Data Control·1980-02-25
• K800048 — LDC CONSTAMETRIC III HIGHT PRESS. SOL.Laboratory Data Control·1980-01-29
• K800047 — LDC UVIII FIXED WAVELENGTH ULTRAVIOLETLaboratory Data Control·1980-01-21
• K791661 — SYSTEM CONTROLLER 720 SERIESWaters Assoc., Inc.·1979-09-24
• K782175 — CARTRIDGE HOLDER, RCM 100Waters Assoc., Inc.·1979-02-15
• K790145 — SOLVENT DELIVERY SYSTEMWaters Assoc., Inc.·1979-02-15
• K781915 — DATA MODULEWaters Assoc., Inc.·1979-01-10
• K781771 — DETECTOR, MODEL 79875A, VARIABLEHewlett-Packard Co.·1978-12-20
• K781379 — MODEL 5000, LIQUID CHROMATOGRAPHYVarian Assoc., Inc.·1978-09-14
• K772364 — AUTO. SAMPLING SYSTEMHewlett-Packard Co.·1978-01-05
• K771156 — MONITOR, LIQ. CHROMATOGRAPHY LC-15 UVThe Perkin-Elmer Corp.·1977-08-02
• K770638 — DETECTOR, UV, MOLEL GC-55Peokin-Elmer Corp.·1977-06-24
• K761351 — L080 SERIES LIQUID CHROMATOGRAPHHewlett-Packard Co.·1977-02-02
• K761219 — SERIES II LIQUID CHROMATOGRAPHThe Perkin-Elmer Corp.·1977-02-01