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FDA 510(k)

DUPONT DIMENSION C-REACTIVE PROTEIN METHOD

K-Number: K945280 · 1995-03-09

ApplicantDupont Medical Products
Decision Date1995-03-09
Product CodeDCK
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

DUPONT DIMENSION C-REACTIVE PROTEIN METHOD is the device name listed in this FDA 510(k) record. The listed applicant is Dupont Medical Products. It received FDA 510(k) clearance on 1995-03-09 under 510(k) number K945280. The device is classified under product code DCK. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DUPONT DIMENSION C-REACTIVE PROTEIN METHOD?

DUPONT DIMENSION C-REACTIVE PROTEIN METHOD is a medical device that received FDA 510(k) clearance on 1995-03-09. The listed applicant is Dupont Medical Products. The 510(k) number is K945280.

When did DUPONT DIMENSION C-REACTIVE PROTEIN METHOD receive FDA 510(k) clearance?

DUPONT DIMENSION C-REACTIVE PROTEIN METHOD received FDA 510(k) clearance on 1995-03-09, under 510(k) number K945280.

Who is the listed applicant for DUPONT DIMENSION C-REACTIVE PROTEIN METHOD?

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

What is the FDA product code for DUPONT DIMENSION C-REACTIVE PROTEIN METHOD?

The FDA product code for DUPONT DIMENSION C-REACTIVE PROTEIN METHOD is DCK.

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Other records listing Dupont Medical Products 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.

K952815DUPONT LIPASE CALIBRATORK950920DUPONT DIMENSION TOTAL PROTEIN METHODK952816LIPASE FLEX REAGENT CARTRIDGEK952412DUPONT ACA(R) URINE DRUGE OS ABUSE CONTROLK944932PHENOBARBITAL FLEX REAGENT CARTRIDGEK941050DUPONT ACA STAR

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Related Devices (Code: DCK)

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.

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Official Source

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