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FDA 510(k)

CRONEX QUANTA SUPER RAPID SR339 RARE EARTH

K-Number: K900318 · 1990-02-05

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1990-02-05
Product CodeEAM
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CRONEX QUANTA SUPER RAPID SR339 RARE EARTH is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1990-02-05 under 510(k) number K900318. The device is classified under product code EAM. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CRONEX QUANTA SUPER RAPID SR339 RARE EARTH?

CRONEX QUANTA SUPER RAPID SR339 RARE EARTH is a medical device that received FDA 510(k) clearance on 1990-02-05. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K900318.

When did CRONEX QUANTA SUPER RAPID SR339 RARE EARTH receive FDA 510(k) clearance?

CRONEX QUANTA SUPER RAPID SR339 RARE EARTH received FDA 510(k) clearance on 1990-02-05, under 510(k) number K900318.

Who is the listed applicant for CRONEX QUANTA SUPER RAPID SR339 RARE EARTH?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CRONEX QUANTA SUPER RAPID SR339 RARE EARTH?

The FDA product code for CRONEX QUANTA SUPER RAPID SR339 RARE EARTH is EAM.

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Other records listing E.I. Dupont DE Nemours & Co., Inc. 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.

K951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYK953724CRONEX RADIATION THERAPY CASSETTEK953725CRONEX RADIATION THERAPY VERIFICATION CASSETTEK951441DUPONT ACA DIGOXIN (DGN A) METHODK950137URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGEK950136URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE

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Related Devices (Code: EAM)

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.

K974423ULTRA-VISION MAMMOGRAPHY DETAIL, ULTRA-VISION MAMMOGRAPHY FAST DETAILSterling Diagnostic Imaging, Inc.K963913MD100 & MM150Konica Medical Corp.K954161JPI INTENSIFYING SCREENJpi Healthcare Co, Ltd.K943822FUJI UM MAMMO SERIES INTENSIFY SCREENS:Fujifilm Medical System U.S.A., Inc.K943823FUJI FG SERIES INTENSIFYING SCREENS: FG-3-4-8-12Fujifilm Medical System U.S.A., Inc.K943821KYOKKO SPEC-SERIES INTENSIFY SCREENS-SPEC,SUPER SPECFujifilm Medical System U.S.A., Inc.

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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