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FDA 510(k)

WATERS(TM) 996 PDA

K-Number: K924347 · 1992-12-11

ApplicantMillipore Corp.
Decision Date1992-12-11
Product CodeKIE
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

WATERS(TM) 996 PDA is the device name listed in this FDA 510(k) record. The listed applicant is Millipore Corp.. It received FDA 510(k) clearance on 1992-12-11 under 510(k) number K924347. The device is classified under product code KIE. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WATERS(TM) 996 PDA?

WATERS(TM) 996 PDA is a medical device that received FDA 510(k) clearance on 1992-12-11. The listed applicant is Millipore Corp.. The 510(k) number is K924347.

When did WATERS(TM) 996 PDA receive FDA 510(k) clearance?

WATERS(TM) 996 PDA received FDA 510(k) clearance on 1992-12-11, under 510(k) number K924347.

Who is the listed applicant for WATERS(TM) 996 PDA?

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

What is the FDA product code for WATERS(TM) 996 PDA?

The FDA product code for WATERS(TM) 996 PDA is KIE.

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Other records listing Millipore 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.

K023892MILLEX VV, GV, AND HV SYRINGE FILTER UNITSK013988MILLEX GP STERILIZING FILTER UNIT, MODEL SLGP 033 RK963717MILLEX - MP FILTER UNIT (SLMPO25SS/SLMPL25SS)K941326ULTRAFREE-CLK934069MILLEX, DUALEX (PLUS, ULTRA)K922388WATERS(TM) LC MODULE I FOR CLINICAL USE

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Related Devices (Code: KIE)

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.

K964588WATERS 515 HPLC PUMP (515)Waters CorporationK935666PERKIN-ELMER SERIES 200 LIQ CHROMATOGRAPHIC PUMPThe Perkin-Elmer Corp.K914841CHROMATOGRAPHY CLINICAL USE 75JQRMillipore Corp.K911299EQUIPMENT/MATERIAL DECONTAMINATING KITRohm and Haas Co.K862506THE WATERS MODEL 990 PHOTODIODE ARRAY DETECTORMillipore Corp.K844947EMIT ANCILLARY REAGENTSSyva Co.

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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