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FDA 510(k)

ISOPURE LC SYSTEM

K-Number: K862178 · 1986-07-14

ApplicantThe Perkin-Elmer Corp.
Decision Date1986-07-14
Product CodeLDM
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ISOPURE LC SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is The Perkin-Elmer Corp.. It received FDA 510(k) clearance on 1986-07-14 under 510(k) number K862178. The device is classified under product code LDM. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ISOPURE LC SYSTEM?

ISOPURE LC SYSTEM is a medical device that received FDA 510(k) clearance on 1986-07-14. The listed applicant is The Perkin-Elmer Corp.. The 510(k) number is K862178.

When did ISOPURE LC SYSTEM receive FDA 510(k) clearance?

ISOPURE LC SYSTEM received FDA 510(k) clearance on 1986-07-14, under 510(k) number K862178.

Who is the listed applicant for ISOPURE LC SYSTEM?

The FDA 510(k) record lists The Perkin-Elmer Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ISOPURE LC SYSTEM?

The FDA product code for ISOPURE LC SYSTEM is LDM.

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Other records listing The Perkin-Elmer Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K935666PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMPK900828PERKIN-ELMER AA 3100 ATOMIC ABSORPTION SPECTRO.K884864PLASMA 40 INDUCT. COUPLED PLASMA EMMISSION SPECTROK884886MODEL 250 LIQUID CHROMOTAGRAPHY PUMPK872737PERKIN-ELMER LC235 DIODE ARRAY DETECTORK872464ION TRAP DETECTOR (ITD)

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Related Devices (Code: LDM)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K960392CDMBio-RadK961557ALLIANCE 2690 SEPARATIONS MODULEWaters CorporationK942451BIO-RAD CLINICAL DATA MANAGEMENT SYSTEMBio-RadK922388WATERS(TM) LC MODULE I FOR CLINICAL USEMillipore Corp.K920136WATERS 717 AUTOSAMPLERMillipore Corp.K903647MODULE 486 VARIABLE WAVELENGTH TUNABLE UV/VIS DETEMillipore Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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