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FDA 510(k)

DU PONT VISTA(R) IMMUNOASSAY SYSTEM

K-Number: K900245 · 1990-04-11

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1990-04-11
Product CodeJJQ
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DU PONT VISTA(R) IMMUNOASSAY SYSTEM 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 1990-04-11 under 510(k) number K900245. The device is classified under product code JJQ. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DU PONT VISTA(R) IMMUNOASSAY SYSTEM?

DU PONT VISTA(R) IMMUNOASSAY SYSTEM is a medical device that received FDA 510(k) clearance on 1990-04-11. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K900245.

When did DU PONT VISTA(R) IMMUNOASSAY SYSTEM receive FDA 510(k) clearance?

DU PONT VISTA(R) IMMUNOASSAY SYSTEM received FDA 510(k) clearance on 1990-04-11, under 510(k) number K900245.

Who is the listed applicant for DU PONT VISTA(R) IMMUNOASSAY SYSTEM?

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 DU PONT VISTA(R) IMMUNOASSAY SYSTEM?

The FDA product code for DU PONT VISTA(R) IMMUNOASSAY SYSTEM is JJQ.

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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: JJQ)

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.

K013371UBIT-IR300 INFRARED SPECTROMETRY SYSTEMOtsuka Pharmaceutical Co., Ltd.K980120DIGENE DML 2000 MICROPLATE LUMINOMETERDigene Corp.K973938ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READERSfri, Inc.K974762STAT TRACKSAwareness Technology, Inc.K962113ANTHOS PHACTS VERSION MICROPLATE READERColumbia Bioscience, Inc.K961183CBI 7520 READERColumbia Bioscience, 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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